BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 28MM/0

    MDR report key: 1822810 · Received August 30, 2010

    Report

    Report Number
    2249697-2010-01161
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K910988
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REOCCURRENCE. PREOP: DISLOCATION. SURGERY: REMOVAL AND HEAD/LINER, SCREW, DOME HOLE P. OUTCOME: CEMENTED IN A 44MM F X3 LINER, 44MM + 2.5 HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 28MM/0 IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA 63960002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R