BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMALL DIAMETER FEMORAL HEAD

    MDR report key: 2912765 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90045
    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 EVENTS OR DETERMINE A ROOT CAUSE. IF ADDITIONAL INFO BECOMES AVAILABLE, THE INFO WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A REVIEW OF A JOURNAL ARTICLE FOUND THAT 14 PTS UNDERWENT 14 REVISION SURGERIES: 8 REVISIONS FOR RECURRENT DISLOCATIONS, 3 REVISIONS FOR LOOSENING OF THE ACETABULAR COMPONENT, 1 REVISION FOR PAINFUL HIP, 1 REVISION FOR FEMORAL STEM LOOSENING, AND 1 REVISION FOR PROTRUSIO ACETABULI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6643 UNKNOWN SMALL DIAMETER FEMORAL HEAD IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R