BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 1961123 · Received January 12, 2011

    Report

    Report Number
    1822565-2011-00030
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    February 24, 2010
    Report Date
    December 16, 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

    EVAL SUMMARY: REVIEW OF SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. THERE ARE NO RETURNED PRODUCTS OR X-RAYS AVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. WITHOUT RETURN OF PRODUCT AND/OR X-RAYS, A PROBABLE CAUSE FOR ALLEGED DEFICIENCY OR PAIN CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL 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 PT WAS REVISED FOR TIBIAL BASEPLATE LOOSENING, PAIN, AND LYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC. 61074283

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention POSTERIOR STABILIZED PROLONG HIGHLY CROSSLINKED| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE -| CATALOG # 00596204214, LOT # 60499009| CATALOG # 00596401752, LOT # 60980295| POLYETHYLENE LPS-FLEX ARTICULAR SURFACE| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE -| CATALOG # 00597206535, LOT # 61203708| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA| POSTERIOR STABILIZED LPS-FLEX FEMORAL COMPONENT