BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR STEM

    MDR report key: 2912767 · Received January 7, 2013

    Report

    Report Number
    9616680-2013-90048
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVAL. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRYKER IMPLANTS WERE REMOVED BECAUSE OF ALTR. REPLACED WITH ZIMMER STEM AND STRYKER LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8002 ABGII MODULAR STEM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R