BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    MDR report key: 8495820 · Received April 9, 2019

    Report

    Report Number
    0002648920-2019-00257
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    June 11, 2018
    Report Date
    April 9, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT WAS INITIALLY REPORTED ON 0001822565-2018-03625. CONCOMITANT MEDICAL PRODUCTS: FEMORAL SIZE G, LT, PART # 00596401751, LOT # 62254530. LPS-FLEX ARTICULAR SURFACE GH 7-10, 10MM, PART # 00596405010, LOT # 6241557. ALL-POLY PATELLA, 38MM X 9.5MM, PART# 00597206538, LOT# 62413073. REFOBACIN BONE CEMENT R, PART # 3003940002, LOT # 235BAE2108. REPORT SOURCE: FOREIGN: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ASEPTIC LOOSENING POST TOTAL KNEE ARTHROPLASTY AND UNDERWENT A FIRST STAGE KNEE REVISION DUE TO INFECTION APPROXIMATELY FOUR YEARS POST IMPLANTATION. IT WAS NOTED THAT THE POLYETHYLENE BEARING SHOWED SIGNS OF WEAR AND PITTING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290776 NEXGEN COMPLETE KNEE SOLUTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62133498

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R