BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3140645 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01829
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 32F ALUMINA CERAMIC LINER. THE OTHER DEVICE NOTED IN THIS REPORT WAS AN UNKNOWN 32 +5 ALUMINA C-TAPER HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S REVISION. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE PATIENT KEPT THEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON REMOVED CERAMIC LINER AND REIMPLANTED A 36F 10DEGREE X3 LINER AS WELL AS REMOVED CERAMIC HEAD AND REIMPLANTED A BILOX 36 UNIVERSAL HEAD WITH A +5 C-TAPER SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242259 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O| R