BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER SYSTEM 6 TOTAL KNEE KIT CONTAINER

    MDR report key: 4974713 · Received July 31, 2015

    Report

    Report Number
    MW5045117
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 25, 2015
    Report Date
    July 31, 2015
    Manufacturer
    STRYKER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STRYKER SYSTEM 6 AND DEPUY SIGMA TOTAL KNEE SETS. DEFECTIVE PLASTIC INSERTS IN THE STRYKER SYSTEM 6 ORTHOPEDIC CONTAINERS. THE PLASTIC INSERTS WERE CRACKED, CHIPPED, PEELING, AND/OR BUBBLING. THE DURATION OF THE PROBLEM IS UNK. MFRS WERE NOT NOTIFIED AND STRYKER HAS REPLACED THEIR SETS AS OF (B)(6) 2015. THE REPLACEMENT INSERTS ARE NO LONGER MADE OF METAL AND PLASTIC, INSTEAD THEY ARE MADE OF GRAPHITE MATERIAL, WHICH SHOULD BE MORE DURABLE. CONTAINERS HAVE TO BE REPROCESSED IN ORDER TO HOUSE REPROCESSED TOTAL KNEE INSTRUMENTS. I HAVE NO MODEL NUMBER OTHER THAN THAT PROVIDED ABOVE, AND NO EXPIRATION DATE, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502129 STRYKER SYSTEM 6 TOTAL KNEE KIT CONTAINER CONTAINER JWH STRYKER
    502130 DEPUY SIGMA TOTAL KNEE SET DEPUY SIGMA TOTAL KNEE SET JWH DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention