BEUDAMED
    FDA Adverse Event Injury Summary report: N

    26MM STD V40 TAPER VIT HEAD

    MDR report key: 1770223 · Received July 21, 2010

    Report

    Report Number
    9616680-2010-00482
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. DEVICE REMAINS IMPLANTED. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAD A BHA ON (B)(6) 2010. AFTERWARD, THE PT HAD A HIP PAIN ON (B)(6). THEREFORE, THE SURGEON TOOK AN X-RAY AND NOTICED THE DISASSOCIATED CENTRAX WITH HEAD FROM THE STEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 26MM STD V40 TAPER VIT HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS CORK NA 33290605

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other