BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LCCK ARTICULAR SURFACE

    MDR report key: 1924226 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01269
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    March 6, 2009
    Report Date
    November 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: INCREASED SHELF LIFE AND IMPLANTATION AFTER EXPIRY DATE COULD HAVE INCREASED THE CHANCES OF INFECTION BUT CANNOT BE CONFIRMED AS ART SURFACE WAS NOT RETURNED FOR ANALYSIS. WITHOUT RETURN OF PRODUCT/X-RAYS, A DEFINITIVE CAUSE FOR INFECTION AND REVISION CANNOT BE DETERMINED. EVAL CODES: MFG RECORDS WERE CHECKED AND THEY ARE CONFORMING TO SPECIFICATIONS. HOWEVER, IT WAS OBSERVED THAT THE ARTICULAR SURFACE COMPONENT HAD EXPIRED IN (B)(6) 2007 BUT WAS IMPLANTED ON (B)(6) 2008. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LCCK ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 56420800

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention NEXGEN STEM EXTENSION OFFSET| NEXGEN STEMMED TIBIAL COMPONENT| CATALOG# 00598802113, LOT# 60068004| NEXGEN LEGACY LCCK FEMORAL COMPONENT| CATALOG# 00599401792, LOT# 60870716| CATALOG# 00598800700, LOT# 60895073