BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 32MM/0

    MDR report key: 1932925 · Received December 14, 2010

    Report

    Report Number
    2249697-2010-01736
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K910988
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PAIN WITH MOTION OF HER HIP. X-RAYS CONFIRM A SEVERE PROBLEM IN THE RIGHT HIP. REMOVING CUP AND REPLACING WITH BIOMET CUSTOM TRI-PHALANGE CUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 32MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA E388MPA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R