BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL GEO.M/S SCREWLESS CUP 50MM

    MDR report key: 2127103 · Received June 6, 2011

    Report

    Report Number
    2249697-2011-00818
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDJ
    PMA / PMN Number
    K925883
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. CAT # 06-2800, LOT # 30250901, DESCRIPTION: PLUS 0 28MM C-TAPER HEAD. CAT # 2043-2850, LOT # UNK, DESCRIPTION: OMNIFIT SER. II CUP INS. 0 DEG. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S FAILED TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FAILED TOTAL HIP ARTHROPLASTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL GEO.M/S SCREWLESS CUP 50MM IMPLANT JDJ STRYKER ORTHOPAEDICS MAHWAH NA P33030

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R