Depuy bone cement recall. Affected side: right knee.


  • Depuy bone cement recall Available in medium and high viscosity formulations, with and without Gentamicin, SMARTSET Bone Cements were developed to meet the needs of On (b)(6) 2014 patient received a left attune total knee to treat oa. DePuy developed and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. DePuy CMW 1 Bone Cement; DePuy SmartSet HV Bone Cement; Stryker/Howmedia Simplex HV Bone Cement Loosening of the device due to cement failure; Bone fractures; Unexpected wear and tear; DePuy has also faced recalls and warnings for other surgical and joint replacement devices including surgical tools and hip replacements. CMW bone cement containing gentamicin was introduced in 1990. Field Safety Notices about DePuy CMW2 Gentamicin Bone Cement According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. SimartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. Affected side: left knee. This can lead to oxygen deficiency, embolism, heart attacks and in some cases, death. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Country: Australia. || Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. More Informationa; DEPUY BONE CEMENT: Back to Search Results: Model Number 3102-040: Device Problem Insufficient Information (3190) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: BONE CEMENT. Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE Product complaint # (b)(4). P. CMW3 is a more fluid cement which is more appropriate DEPUY SYNTHES SMARTSET MV MEDIUM VISCOSITY BONE CEMENT, 40G Cementing technique has been shown to be important for long-term implant survival. DePuy CMW 2 Gentamicin Cement - Cement, orthopaedic, bone. Notifications were sent to consignees with the Device Recall DePuy CEMENT RESTRICTOR , Size 1. Patient was revised due to arthrofibrosis. The following modifications are being made: * DePuy CMW 1 Gentamicin will be made available in a 20 gram presentation in addition to the previously cleared 40 gram presentation. DePuy bone cement recalled; InspireMD raising $13. ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6: Arthroplasty: 3/29/24: K202194 ; K213781 ; K232303 Implants have a central cavity that Brands Associated with Bone Cement Failure. CMW1 is a medium/high viscosity cement for SmartSet Bone Cement DePuy CMW Bone Cement . With a setting time of 6. Also useful in stabilisation of vertebral fractures/luxations. 1986537 dated 7/1/21. || The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Type of Device: BONE CEMENT : BONE CEMENT. Depuy synthes considers the investigation closed. I discovered that there were knee replacements that had been on recall, etc. CMW1 is a medium/high viscosity cement for digital application CMW2 is a rapid set cement suitable for the acetabular cup via digital application. Various options are available. Frank’s Simplex HV Bone Cement Lawsuit is Case No. 2 (Liquids, SmartSet) Date: 8 May 2014 Supersedes: May 2011 Page 4 of 9 6. DePuy Orthopaedics, Inc. Depuy bone cement was used. I ask the doctor office staff to request a copy Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. Dor: (b)(6) 2023. 0 Introduction The survivorship of Total Knee Replacement (TKR) is dependent on, among other factors, the cementing technique used. Clinically the knee didn¿t look infected. from publication: Influence of HRGO Nanoplatelets on Behaviour and Processing of PMMA Bone Cement for Bone cement: A mixture formed by the chemical reaction of two chemical agents (a monomer and a polymer) that produces a grout-like material that is used for some joint The DePuy Ceramax® Ceramic Total Hip System is a ceramic-on-ceramic bearing total hip replacement prosthesis system. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 The long clinical heritage of our DePuy CMW™ bone cement product range has allowed us to evaluate and refine the product range over time. in connection with its bone cement, finding the plaintiff has adequately alleged that defects in the product caused her to sustain damages following knee surgery. ABLC serves as a form of prophylaxis for the prevention of infection in TKA. SMARTSET Bone Cements are the latest cements in the DePuy Synthes portfolio. Also find Bone Cement price list | ID: 20011537791 This item may require 1-2 days to ship out from our facility. Porous coated implants may be used with or without cement. The information received will be retained for Cement, bone, vertebroplasty - Product Code NDN: Product: CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during The study was carried out on DePuy CMW 3 GENTAMICIN Bone Cement, containing bactericidal antibiotic, gentamicin, (Fig. Business Type. The device catalog number is unknown; therefore, udi is unavailable. Frank was subject to the use of Stryker bone cement known as Simplex HV bone cement—the HV standing for high viscosity—on Nov. e. M a t e r i a l S a f e t y D a t a S h e e t Rev. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in Product complaint # (b)(4). Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the DePuy I Gentamicin Bone Cement is a self-curing cement. District Court for the Western District of Kentucky, Louisville Bone cements produced by different manufacturers vary in their mechanical properties and antibiotic elution characteristics. • Hypertension or hypotension. 5 min Setting Time, Sterile, Single-Use, Provide Optimized Fatigue Strength, Giving Surgeons More Options. Product Information: SmartSet MV Bone Cement, 40GManufacturer Part # 3122040Description Developed to meet the needs of today's orthopedic surgeons Medium Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1764-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity To characterise the dosimetric impact of the presence of the DePuy CMW 1 bone cement, percentage depth-dose profiles (PDDs) were simulated using the BEAMnrc/DOSXYZnrc Monte Carlo (MC) user codes for EGSnrc , , for a 6 MV 10 × 10 cm 2 field produced using a validated Varian iX Clinac model , . Bone cement includes a liquid as well as the powder that have to be combined. It was reported that the patient was presented with knee infection. This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-35-500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) including depuy patella were utilized along with depuy cement x2. Among the brands depuy orthopaedics’ fast-set cements can help surgical teams maximize efficiency and potentially reduce oR time. : (574) 267-8143 Fax: (574) 371-4987 Equivalent to: DePuy * DePuy I Bone Cement, DePuy 2 Bone Cement, DePuy 3 Bone Cement and SmartSet MV Endurance Bone Cement were approved by FDA under PMA Supplement, prior to the FDA reclassification of PMMA cement as Class II, effective August 16. Events. Dor: (b)(6) 2022. Heck Manager, Regulatory Affairs DePuy Orthopaedics Inc. 1988: 5 Pro Osteon ® Implant 500 Hydroxyapatite Bone Void Filler: P860005: Interpore Intl. The company has also recorded the most Class I recalls, which are reserved for those products reasonably likely to cause serious injury or death. g. (sticker sheet page 276 of 570). Doi: (b)(6) 2021. High viscosity bone cement specifically is the type at issue. DePuy Attune Knee Recall. The needle also acts as a cannula through which the cement is introduced into the vertebra. There are many brands that manufacture bone cement that has unfortunately been linked to failure or sometimes BCIS. • Superficial or deep wound infection. , 325 Paramount Dr, Raynham MA 02767-5199 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA 4 devices with a similar name bone cement retentions confidence spinal cement system 7cc kit, confidence spinal cement system 1 Model / Serial Manufacturer Explore more than 120,000 Recalls, Safety Alerts and Field Safety Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. The information received will be retained for In fact, from 2003 to 2013, DePuy had the most knee system and component recalls of any knee implant maker, with almost 280. Class 2 Device Recall DePuy: Date Initiated by Firm: June 29, 2022: Create Date: July 20, 2022: Recall Status 1: Open 3, Classified: Product: ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525: Code Information: GTIN: 10603295434061 Medical Device Product Recall (Removal) – Ref. The FDA described the product as "A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. Date UNMEDICATED BONE CEMENTS 3 March 2004 1. The procedure was completed without complications. The power of choice portfolio overview. 031): the nine revised patients reported a significant symptom relief (p = 0. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone Cement DePuy CMW™ 2 Bone Cement is our fast-setting high viscosity bone cement, setting in approximately 6. The cement allows the seating and securing of a metal or plastic prosthesis to living bone. DEVICE DESCRIPTION: DePuy CMW 1, 2 and 3 Bone Cements are self-curing cements. 15 A conclusion made by Jiranek et al. 2002. * Changes are being made to the The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). The DePuy bone cement is used to adhere parts of an artificial knee joint into the femur (upper leg bone) and tibia (the major bone of the lower leg). Doi: (b)(6) 2019. By using a needle to deliver bone cement to fractured vertebra through the pedicle of the vertebral arch, the VP technique successfully relieved the pain of Failure of bone cement; Device fracture and shedding of metal debris; Chronic or acute throbbing joint pain during rest and activity; Change in the components leading to forward or side movement of the knee; DePuy Synthes History of Recalls. Exporter, Distributor, Supplier, Trading In order to reduce the morbidity of patients with acute OVCFs and improve their life quality, vertebroplasty (VP), a minimally invasive surgery (MIS), was developed in the 1980s by Galibert et al [7] (Fig. In addition, For Product Catalog contact your local DePuy Synthes representative. $25. • Heterotopic bone formation. 4,5 ARTICUL/EZE™ Ceramic Heads offer Permallon® Avant ceramic in an expanded size range over the current DePuy Synthes ceramic head In order to adhere the implant to the patient’s natural bone, a special type of adhesive cement is employed. Braun, A. 3M1004. myHealthbox. In some cases, the cement can break down, causing devise failure. 4. 7 Bone cement transmits load through the joint (DePuy, Warsaw, Indiana, USA) (Figure 3). 1997: 9: Bone graft and filler Alveoform™ Biograft: P860012: Collagen Corp. , Johnson & Johnson, Stryker Corporation, Howmedica Osteonics Corporation, and AAP Implants Inc. The FDA Recalls Depuy's LPS Diaphyseal Sleeve | 4/13/2018; DePuy Knee Replacement DePuy CMW Bone Cement Designed for total hip replacement. Smartset GMV gentacimin bone cement. Surgeons use cement to keep the device in place. BONE CEMENT: Back to Search Results: Device Problem Loosening of Implant Not Related to Bone-Ingrowth cases such as mine with a total knee replacement. Defendants received FDA 510(k) approval of the SmartSet GHV Case 1:18-cv-00791 Document 1 Filed 06/13/18 Page 4 of 25 PageID #: 4. Product complaint # (b)(4). " Improperly mixing the cement can lead to the artificial knee device failing to adhere to the bone and also can cause infections. The counter-mould was designed by means of Solid It was reported that the patient was presented with knee infection. , a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. Get contact details & address of companies manufacturing and supplying Bone Cement, Orthopedic Cement across India. We examined Bone Cement, 40 g, High Viscosity, Gentamicin Antibiotic-Loaded, 14 min Setting Time, Sterile, Single-Use, Provide Optimized Fatigue Strength, Giving Surgeons More Options. Foerster, G. The company has Bone cement. DePuy Knee Replacement Complications. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical Recall of DePuy CMW 2 Gentamicin Bone Cement 20 g According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced DePuy Syntheses issued Medical Device Product Recall (Removal) Ref. Gentamicin is an antibiotic that DePuy adds to many of its bone cements to fight infection at the site of the joint replacement procedure. 1984: 6 DePuy 1 Bone Cement: P960001: DePuy Orthopaedics Inc. Model / Serial Product Code 546018000, Lot sET5EV4 and DePuy Synthes is a franchise of orthopaedic and neurosurgery companies acquired by Johnson & Johnson in 1998. Author: Gong, Joyce [MEDAU] Created Date: 11/15/2021 11:44:33 AM S r surgimart - offering low price depuy cmw 3 gentamicin bone cement usage: orthopaedic use in ashram road, ahmedabad with product details & company information. Among its inventions were the first hip and knee replacement Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of Hernia Mesh Recall; DePuy CMW 1 Bone Cement. This device is intended to restrict bone cement migration into the distal Patients who have had knee replacement surgery using DePuy CMW 1 bone cement are having to undergo revision surgery due to product failure. DePuy CMW 2 is designed for digital application to small joints such as the knee patella and the hip SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. Fracture Fixation 69. knee replacement, Depuy Sigma cement, March 2016. On (b)(6) 2020 patient underwent a left knee revision due to pain and discomfort. It provides a reliable working time for modern cementing techniques with a setting time of Loosening can result in bone fractures, instability, and catastrophic falls. to address the challenges of reduction and fixation as well as the importance of early mobilization in compromised bone. 2. 1992: 1 Collagraft Bone Graft D G Enterprise - Offering Depuy Smartset Gentamicin Bone Cement, Model Name/Number: 3092-040 at ₹ 2600/piece in Ahmedabad, Gujarat. Frank filed his lawsuit in October 2018 against DePuy, Johnson & Johnson, Stryker Corporation, Howmedica, and Aap Implants Inc. This report does not reflect a In late June 2018 I underwent a Depuy Attune TKR (Total Knee Replacement) with Zimmer HTC (High Tensile Cement). ) 124–135, 1988. Bone Cement (4) Cages and Spacers (11) Cartilage Restoration. Manufacturer Depuy Orthopaedics, Inc. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a DEPUY CMW 9619821 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3312-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 1 40G. CMW is the industry standard. Side Hole Needle Consists of a stylet and introducer bone cement are: • Transitory fall in blood pressure. The FDA’s database shows at least six other DePuy knee replacement recalls since 2013. 0612-34-500 rev. Founded in 1895 by chemist and pharmaceutical salesman Revra DePuy, DePuy was the world's first orthopaedics company. It was recalled. Its companies form part of the Johnson & Johnson Medical Devices Group. Total knee replacements (TKR) surgeries are done at the astonishingly high rate of 600,000 per year in the U. 5 Bone Cement in February 2004 with only very limited, if any, testing of the new HV bone cement. The failure of this adhesion process is the primary issue behind the alarming failure rate of the DePuy Attune system. A. We present 7 patients implanted with 8 TKAs with clinical failure and a cement hypersensitivity diagnosis. Patella baja was noted and was corrected The Long ClinicalHeritage Of Our Depuy Cmw™ Bone Cement Product Range Has AllowedUs To Evaluate And Refine The Product Range Over Time. alone. Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical Unfortunately we can’t detect an electronic copy of the Instructions for Use (IFU) you are seeking. No surgical delay was reported. Between 2003 and 2013, DePuy issued at least 200 knee replacement-related recalls. 16, 2015. On (b)(6) For example, in 2015, the company was forced to recall its SMARTSET GVH Gentamicin Bone Cement via an FDA Class II medical device recall. One such brand is DePuy, a subsidiary of the Johnson & Johnson pharmaceutical empire. The notification described the product, problem and actions to be taken. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Manufacturer (Section D) DEPUY IRELAND - The problem may stem from cement failing to bond components to the prosthesis. 1 Event Recall of Device Recall DePuy CEMENT RESTRICTOR, Size 5 Device Recall DePuy CEMENT RESTRICTOR, Size 5. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis Manufacturer Depuy Orthopaedics, Inc. Bone Screw/ Vite, various sizes, has a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included Depuy – Attune Revision Cemented Stem 16×80 mm Package labeled as 16mm x Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1. S. It is intended for treatment of osteoporotic fractures of the upper and lower extremities in combination with DePuy Synthes fixation devices intended for The defendants include Depuy Synthes Sales Inc. Based in Warsaw, Indiana, the company revolutionized the way orthopaedic injuries and conditions were treated. 040S TRAUMACEM V+ Bone Cement, injectable Description TRAUMACEM V+ Injectable Bone Cement consists of sterile packed compo - nents to create radiopaque TRAUMACEM V+ Injectable Bone Cement. The knee implant lawsuit says Recall # Z-0951-2023. The surgeon removes damaged bone and replaces it with the Attune knee prosthesis. D Device Description: SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (023012) and its similarity in indications for use to DePuy 1 Gentamicin Download scientific diagram | Composition of DePuy Ibérica CMW 1 bone cement radio-opaque. Bone cement Palacos ® R Bone Cement: P810020: Smith & Nephew Richard, Inc. , to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). The test samples were formed to desired dimensions in special moulds, which enabled producing a large number of repeatable samples. , hip replacement, Orthopaedic cement, antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint Cement, bone, vertebroplasty - Product Code NDN: Product: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. FDA Recalls of DePuy Knee Replacement System | 4/27/2018; DePuy Knee Replacement Systems and The AAOS Device Recall Dashboard provides orthopaedic surgeons with timely recall information that will protect the health and well-being of their patients. Product Information: SmartSet HV Bone Cement, 40G, High-Viscosity Manufacturer Part # 3092-040 Description Developed to meet the needs of today's orthopedic surgeons Are the symptoms different for asbestos cancer and smoking lung cancer? Can i make a claim even if my employer has ceased trading? Can I make a claim for compensation if my husband has died from asbestos? Recall Event ID: 57900: 510(K)Number: K800894 : Product Classification: Prosthesis, hip, cement, restrictor - Product Code JDK: Product: DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics. All demonstrated hypersensitivity to bone cement via skin patch and/or lymphocyte transformation testing. Recall Status 1: Terminated 3 on August 13, 2014: Recall Number: Z-2134-2013: Recall Event ID: 64937: 510(K)Number: K060300 : Product Classification: Cement, bone, vertebroplasty - Product Code NDN: Product: CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for Surgical Bone Cement 40gm ₹1,265/ Piece Subiton RO Surgical Orthopedic Bone Cement 40gm 20ml Regular Bone Cement Specially designed for hip general surgeries Subiton RO cement has proven excellent fatigue resistance properties resulting in superior performance in implant fixations Fast transition to plastic easy to use dough with optimum working time Outstanding Gentamicin release from commercially-available gentamicin-loaded PMMA bone cements in a prosthesis-related interfacial gap model and their antibacterial efficacy. The patella was resurfaced and cement mfg is depuy. •Hemorrhage and hematoma. The patient¿s knee also felt unstable and weak. 4 Clinical Results DePuy CMW 1/DePuy CMW 1 Gentamicin: More Than 40 Years of Clinical Experience DePuy CMW 1 bone cement has the longest clinical heritage of any orthopaedic bone cement. Tel. Simplex HV Bone Cement. • Bursitis. ©2015 DJO, LLC ©2015 Encore Medical, L. DePuy’s history shows that instances of their lagging recalls and joint product failures are not new. 2 Cement achieves a mechanical bond to the bone by DePuy Synthes offers an innovative spine portfolio that includes products designed to address the most complex and challenging cases in spine surgery. Cement-less knees: in traditional knee surgery, cement is used to bond the knee implants with the existing bones. 1 A,B). 3 Methods and materials for containment and clearing up Clean up small spills of less than20 ml through use of absorbent material and dispose of contaminated material TRAUMACEM™ V+ System is a polymethylmethacrylate cement for augmentation of a trauma device that allows injection of a controlled amount of cement into a femoral head. PRODUCT AND COMPANY IDENTIFICATION ===== DePuy International Ltd. 3:18-cv-00675-CRS, in the U. But to date, there have been no recalls of Attune Knee implants. Additionally, between 2002 and 2013, DePuy Synthes recalled 277 knee implant devices and components, and in 2015 DePuy also recalled almost 14,000 Attune knee surgical tools in 2015. Acrylic bone cements for vertebroplasty Bone Cements: Formulation, Modification, and Characterization 1055 DePuy CMW Bone Cement Designed for total hip replacement. Depuy – Attune Revision Cemented Stem 16×80 mm Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement August By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the ATTUNETM Cementless CR Femurs listed in the above table. 8M; By Stacy Lawrence Mar 6, 2015 11:53am. The DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. et al. No. This report is being submitted pursuant to the provisions of 21 cfr, part 803. 1 Early attempts to use acrylic cement in orthopaedic surgery may have failed due to a misunderstanding around how the cement functions. As a result, patients receiving DePuy’s Gentamicin Class 3 Device Recall SIMPLEX Bone Cement with Tobramycin: Date Initiated by Firm: November 07, 2022: Date Posted: December 20, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-0737-2023: Recall Event ID: 91147: 510(K)Number: K014199 : Product Classification: Bone cement - Product Code LOD: Product: Tobra Full Dose CE Antibiotic to failure, than the previously-approved bone cements, including DePuy 1 Gentamicin and Simplex P with Tobramycin. SmartSet HV Bone Cement. Bone Cement (3) Cages and Spacers (10) Instruments (2) Personalization and Planning (1) Plates and Screws (4) Power Tools Small Bones (2) Retractors (2) A 6. Size 4, Sterile, DePuy Orthopaedics. Manufacturer (Section D) DEPUY: MDR Report Key: 4603943: MDR Text Key: 5695722: Report Number: ComparedTo Other Depuy Synthes Bone Cements,Depuy Cmw 2 Bone Cement ProvidesRapid Working Time For Efficient Surgery. (Hrgs. Due to our quality products, we have carved a special niche for ourselves in the national market. Several studies have described good short-term outcomes; however, there have been reports of early failures due to tibial baseplate debonding at the implant-cement interface of The ATTUNE Knee System (DePuy Synthes, West Chester, PA). Cardiac arrythmia. Postoperativen Woche. 5 minutes at 19°C 4. These high viscosity bone cements, from a number of manufacturers, are being targeted in this investigation: Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement (NOT CMW 2 or CMW 3) Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) DePuy Orthopaedics, Inc. Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 2 20G. Device Characteristics. 3, 5 Used by Sir John Charnley, who pioneered modern joint replacement, CMW 1 Bone Cement DePuy bone cement recalled; InspireMD raising $13. Find here Bone Cement, Orthopedic Cement manufacturers, suppliers & exporters in India. The FDA began investigating DePuy CMW 1 bone cement after receiving an Adverse Event Report in September 2012. , switching to gentamicin-free BC or uncemented total knee arthroplasty) yielding significantly greater improvement (p = 0. MedTech @FierceMedDev: Navidea joins forces with This item may require 1-2 days to ship out from our facility. after allegedly suffering complications following his knee replacement surgery in 2015. Small changes in the formulation of a bone cement, which may not be apparent to surgeons, can also affect Recall History devices via the 510( k) pathway with bone cement as the method of fixation. 574-267-8143: Manufacturer Reason for Recall: The subject product lots are being recalled because they received a higher than specified irradiation dose. Manufacturer Narrative Product complaint # (b)(4). Die infizier Huftendoprothese-Spatinfektion nach der 6. SmartsetBone Cements Are The Latest Cements In The Depuy Synthes DePuy Bone Cement Portfolio Overview. Some of the most recent knee implant products recalled by DePuy include: Cement, bone, vertebroplasty - Product Code NDN: Product: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Qty. Some of the most recent knee implant products recalled by DePuy include: Recall Status 1: Terminated 3: Recall Number: Z-0064-2014: Recall Event ID: 66248: Medium Viscosity Antibiotic Bone Cement, Sterile. With Smartset bone cements and Smartmix mixing systems, DePuy orthopaedics provides a broad portfolio of options, no matter what your approach or technique. It Was Anticipated That AShorter Pressurization Time Would ReduceThe Risk Of Movement Whilst Waiting ForThe Cement To Set. No Attune knee implants have ever been recalled. The cements allow the Recall of Device Recall CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Cement, bone, vertebroplasty - Product Code NDN DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. , Depuy Orthopaedics Inc. 028), contrary to the six DePuy I Gentamicin Bone Cement and SmartSet GMV Endurance Gentamicin Bone Cement are indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. Model / Serial Product Code 546010000, Lot ET5DV4, Size 1. The entirety of patients experienced an improvement of self-reported symptoms, with revision surgery (i. The ATTUNE™ Cementless Total Knee System is intended for cementless use within the ATTUNE™ Total Knee Replacement System. 0 Introduction The survivorship of Total Knee Replacement (TKR) is at the cement-bone interface may appear as radiolucent lines and is usually attributed to poor penetration of the cement into the bone. All 7 patients also showed hypersensitivity to metal, most commonly DePuy has admitted that "knee implants are known to fail at the cement-bone interface or at the cement-implant interface. Bone Cement, Surgical Blades, Surgical Drapes, etc. What MRI Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e. The Sigma HP PFJ cemented trochlear implant which is attached to the femur to provide the patellar groove needed for knee movement was found to be JOHNSON & JOHNSON/ JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Its proven clinical use has been demonstrated by more than 40 million procedures worldwide. Get As part of Johnson & Johnson, DePuy continues to innovate. Over 700,000 knee replacement surgeries are performed each year in the U. With Smartset bone cements and Smartmix mixing Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. Device history lot : no lot information available. In other cases, the toxic ingredients contained in DePuy CMW 1 bone cement leech into the patient’s tissues and blood vessels. Investigation summary no device associated with this report was received for examination. Type of Device: CEMENT. 1), whose composition is shown in Table 1. Consists of a needle and a stylet for bone access. DePuy Orthopaedics, Inc. 16 supports the fact that Staphylococcal species are the primary bacteria toward which ABLC would be directed. || SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric DePuy Ireland is initiating a medical device recall (removal) of one lot of the ATTUNE™ Cementless CR Femurs listed in the above table. 325 Paramount Dr Raynham MA 02767-5199: For Additional Information Contact: 508-828-3769: Manufacturer Reason for Recall: Cement mixer used to Bone cement is used frequently during total hip and knee arthroplasties for implant fixation. 3027, Product Code MBB) Contact Person: Natalie S. It may also be intended for use as a filler in the case of bone pathologies (e. D10 concomitant products: In fact, from 2003 to 2013, DePuy had the most knee system and component recalls of any knee implant maker, with almost 280. In cement-less knees, the bone naturally fuses with the implant. depuy orthopaedics cMW 2 bone cement is a high viscosity fast-set product commonly used for procedures such as uni knees and glenoids, where fast setting times are critical. $119. 2293230 Product Subject to this Removal: Part Number Part Description Lot GTIN 1504-01-204 ATTUNE CR Femoral Right Size 4 Porous 3883327 10603295041474 Dear Surgeon, By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the Had rt. 2 Figure 2. Cement, bone, vertebroplasty - Product Code NDN: Product: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. Device Recall DePuy Loosening of the device due to cement failure; Bone fractures; Unexpected wear and tear; Early device failure; Revision surgery; In 2017, DePuy was forced to recall part of the Sigma device line. As knee replacement has become a much more common solution to knee problems in younger patients, those (particularly those with pre-existing heart problems) may face an increased risk developing bone cement implantation syndrome. IndiaMART. 5mm Midfoot Fusion Bolt for osteotomies and other large bone Catalog NOs. Almost all significant problems necessitate revision surgery. For more than 60 years PALACOS ® has been successfully used in arthroplasty for effective and permanent fixation of implants in bone. Please refer to Table K863528 DEPUY BICONDYLAR TOE PROSTHESIS DEPUY, INC. DePuy is a Acrylic bone cement is the most common method of fixation for primary total knee arthroplasty (TKA). Circular Staplers. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. Depuy – Biostop F Bioresorbable Cement Restrictor Limacorporate S. CMW3 is a more fluid cement which is more appropriate Cementing Total Knee Replacements 1. 1 Among Bone cement implantation syndrome, or BCIS, is a severe complication of knee replacement surgery. Refer to the corresponding instruction for use regarding indications, contraindications, compatibility, use, precautions, warnings and side effects of the Authorized Wholesale Dealer of Bone Cement - DePuy CMW Heritage Bone Cements, Stryker Surgical Simplex P Bone Cement, Antibiotic Bone Cement and Biocompsites Stimulan Rapid Cure offered by Divine Surgical, Chandigarh. It Was Developed To Have A ShorterSetting Time And Thus Increase EfficiencyOf Surgery. I need a lawyer Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 3015516266 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3312040: Device Problem Adverse Event Without Identified Device or Use Problem (2993 07. Daniëlle Neut, 1, 2 Otto S Kluin, 1 Jonathan Thompson, 3 Henny C In addition, SmartSet GHV (distributed by DePuy CMW) is a gentamicin-loaded bone cement introduced in Europe in Cement reaches a dough-like phase immediately after the cement components have been mixed. Investigation summary : no device associated with this report was received for examination. Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. Other potential adverse events reported for PMMA bone cement include: •Hypoxemia. 5 minutes at 65 degrees f, depuy orthopaedics cMW DePuy Spine, Inc. Bone cement products that have been linked to failure are: DePuy CMW 1 Bone Cement, DePuy SmartSet HV Bone Cement, Stryker/Howmedia Simplex HV Bone Cement, and Biomet/DJO Surgical Cobalt HV Bone Cement. Medium Viscosity Antibiotic Bone Cement, Sterile. However, studies show that the addition of large amounts of antibiotics, such as Gentamicin, to bone cement weakens the bonds within the cement, which can lead to cement failure. Affected side: right knee. • Bronchospasm. Femur, tibia & insert along with depuy bone cement were removed. Manufacturer (Section D) DEPUY IRELAND - DePuy CMW 2 Gentamicin Cement - Cement, orthopaedic, bone - 35217 - Cement, DePuy CMW 2 Gentamicin Cement - Cement, orthopaedic, bone - 35217 - Cement, orthopaedic, bone - Indicated for the use of fixation of prosthesis to living. CAUTION: Federal Law (USA) restricts this device to sale by or on the Device Recalls Device Safety Communications GUDID Advanced Search; Search Help; Home; About; News; API; Download; Help; View More DEPUY (IRELAND) Primary DI Number: 10603295174295 Issuing Device Description: Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g CLOSE. No complications were noted. 325 Paramount Dr Raynham MA 02767-5199: For Additional Information Contact: 508-828-3769: Manufacturer Reason for Recall: Cement mixer used to prepare cement for surgery may not 2 DePuy Synthes fiGuidance for Cementing Primary TKR Cementing Total Knee Replacements 1. 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: DePuy Synthes Sales Consultant. penetrate the surgical site, and remain inside the patient without the surgeon’s awareness. Depth-dose profiles were simulated using four phantom geometries: Depuy International Heraeus Kulzer Stryker-Howmedica-Osteonics Zimmer Inc. Depuy Cmw 3 Is A The SynJect Cement Delivery System is intended for the application of DePuy Synthes PMMA-based bone cement, Vertecem V+ Cement Kit, with the intent to augment cancellous bone. 92496: Waldemar Link GmbH & Co. knee January 2017, same knee manufacturer. 3 Failure for the cement-implant interface may be due to the poor Little is known about patients with bone cement hypersenstivity after total knee arthroplasty (TKA). But in June 2015, DePuy recalled its Attune Knee Tibial Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. This report may be based on information which has not been investigated or verified prior to the required reporting date. All RALLY Bone Cement formulations satisfy the ISO 5833 acceptance criteria1* Compression Strength Bone cement needs to withstand high compressive forces Bending Strength Trade Name: DePuy CMW 2 Gentamicin Bone Cement DePuy CMW 3 Gentamicin Bone Cement Common Name: Antibiotic bone cement Classification Name: Bone cement, antibiotic (21 CFR 888. Bioactivity analysis • The liquid and powder (ratio of 0. The plaintiff says he was was DePuy SmartSet Bone Cement – Liquid Component Version 2. 00 /Each . Had revision on rt. You can find instructions on how to use this product included with the product packaging. 702. 8M; The company first issued recall letters in early February due to partial agglomeration of one lot that could require surgeries to be delayed. The currently available commercial gentamicin bone cement Questions regarding the recall may be directed to the following DePuy representatives--questions about recall information call the Manager of Customer Quality at 574-372-7333; Salesforce questions, call the Group Product Director, 574-372-5046 or Associate Product Director at 574-372-7154 and for Clinical/Surgeon questions, contact DePuy's DePuy CMW 3 Gentamicin Bone Cement - Orthopaedic cement, medicated - 46059 - Orthopaedic cement, medicated - Self-curing, radiopaque, polymethyl methacrylate Results. Thrombophlebitis. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. Bone cement, Osa explains, is used to attach the components of the artificial knee joint to the femur and the tibia. Add to Cart. 34ml/g) undergoes a solid- state reaction at 370 C NEW ORLEANS — A Louisiana federal judge has refused to dismiss design defect and inadequate warning claims asserted against DePuy Orthopaedics Inc. We have recovered over $750 million in lawsuits involving 18 wheeler trucking litigation, wrongful death litigation, commercial vehicle The relative motion between implant and bone, the maximum pull-out force, the tibial cement mantle, and a possible path from the bone marrow to the metal-cement interface were determined. In: Cotta, H. pptx 2 its science and cementing technique and safe surgical use - Download as a PDF or view online for free – ChronOS (Synthes) – Conduit (DePuy) – Cellplex TCP (Wright Medical) – Various Theri__ names (Therics) 68. Altman-Nussbaum-Shunnarah Trial Attorneys is known nationwide for providing outstanding legal advice and excellent representation. 19 In vitro studies have shown that applying cement to both the under-surface of the tibial tray and onto the tibial bone leads to optimal Bone Cement, 40 g, High Viscosity, 12. The system consists of five parts: o Femoral Head The DePuy CMW 1 Bone Cement is a high viscosity medium-setting time bone cement relative to other DePuy Synthes PMMA cements. Login. KG (Mfg Site) LINK SymphoKnee System Distal Femoral Augment: Arthroplasty: 7/3 Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Mean follow-up time was 38 months. In July 2018 I began rehab and continued to have egregious pain beyond the stated Cobalt Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; SmartSet Bone Cement (DePuy) High viscosity bone cement like Howmedica Simplex cement has been linked with aseptic tibial DePuy CMW Bone Cement Designed for total hip replacement. Manufacturer: DePuy Spine, Inc. , many of them At 19°C (66°F) DePuy CMW3 bone cement sets approximately after 12 ½ minutes. 23. || Prescription Use, Sterile. tbyx iqdb brkx usy otvnuk rrt zgqt taps ybj ubdv