BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4946360 · Received July 28, 2015

    Report

    Report Number
    0002249697-2015-02492
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 7, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN SYSTEM 12 HOODED LINER. AN EVENT REGARDING WEAR INVOLVING AN UNKNOWN LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW WAS NOT PERFORMED AS THE LOT ID IS UNKNOWN. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED THE LOT ID IS UNKNOWN. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, X-RAYS, OPERATIVE REPORTS AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT HIP DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488948 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention