BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIB BEARING COMP ROT/HIN KNEE

    MDR report key: 2885229 · Received December 18, 2012

    Report

    Report Number
    9610726-2012-00407
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K811630
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6485-0-020 LOT # FRAGD DESCRIPTION: MRS CONDYLE RT, CAT #UNK LOT # UNK DESCRIPTION: FEMORAL BUSHING. CAT # UNK, LOT # UNK DESCRIPTION: BUMPER. CAT # UNK, LOT # UNK DESCRIPTION: MRS AXEL. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT PRESENTED WITH AXEL THAT HAD SHOT OUT OF HOME. AXEL HAD SLID OUT OF THE HINGE PORTION OF KNEE. ONCE SURGEON GOT IN ONE OF THE BUSHINGS WAS TOTALLY GONE, AND THE OTHER WAS PARTIALLY GONE. ASSUMPTION THAT AXEL CAME OUT BECAUSE THE BUSHINGS WERE GONE. SURGEON TOOK OPTION TO PUT IN GMRS COMPONENTS BACK IN DUE TO BIGGER AXEL. FIRST OPERATION AFTER INITIAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIB BEARING COMP ROT/HIN KNEE IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA FUHZD

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention