BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABC ALUMINA C-TAPER HEAD

    MDR report key: 935601 · Received October 31, 2007

    Report

    Report Number
    2249697-2007-00153
    Event Type
    Injury
    Date Received
    October 31, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 27, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    K991952
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN AT THIS TIME WHICH DEVICE CAUSED THE EVENT. CAT# 2047-3258 LOT# 2096350421 LINER WAS ALSO FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT PRESENTED IN OFFICE WITH HIP PAIN IN 2007, BROKEN FEMORAL HEAD IMPLANT ON X-RAY-POSSIBLE BROKEN ALUMINA LINER, PT STILL WT BEARING. UNABLE TO SCHEDULE REVISION FHA IMMEDIATELY AS PT IS SCHEDULED FOR HEART CATHETERIZATION THE FOLLOWING MONTH. REV. RIGHT THA WILL BE SCHEDULED AS SOON AS PATIENT IS CLEARED FOR SURGERY. UPON ENTRY TO JOINT SPACE, DR NOTED THAT THE FEMORAL HEAD AND LINER WERE BROKEN AND THESE WAS A NOTCH AT THE 10 POSITION ON THE CUP TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABC ALUMINA C-TAPER HEAD IMPLANT MRA STRYKER ORTHOPAEDICS MAHWAH NA RT6042

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention