BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LARGE DIAMETER FEMORAL HEAD

    MDR report key: 2912774 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90048
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A JOURNAL ARTICLE. THERE ARE INSUFFICIENT DETAILS AVAILABLE AT THIS TIME TO CONFIRM THE REPORTED EVENT OR DETERMINE A ROOT CAUSE. IF ADD'L INFO BECOMES AVAILABLE, THE INFO WILL BE SUBMITTED IN A F/U REPORT.

    Description of Event or Problem · 1

    A REVIEW OF A JOURNAL ARTICLE FOUND THAT 6 PTS WHO UNDERWENT REVISION SURGERY DUE TO RECURRENT DISLOCATION, THREE PTS RECEIVED REVISION OF THEIR ACETABULAR COMPONENTS DUE TO MIGRATION AND LOOSENING AT 1, 2, AND 11 MONTHS AFTER INDEX ARTHROPLASTY, THREE OTHER PTS WERE REVISED TO LOCKING LINERS AT 1, 6, AND 9 MONTHS AFTER INDEX ARTHROPLASTY, AND TWO PTS WERE REVISED WITH UPSIZING OF THE FEMORAL HEAD COMPONENT AND REPLACEMENT OF ACETABULAR COMPONENTS DUE TO LOOSENING AT 4 AND 58 MONTHS AFTER INDEX TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6644 UNK LARGE DIAMETER FEMORAL HEAD IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R