BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER COCR LFIT HEAD 40MM/+10

    MDR report key: 2634057 · Received June 21, 2012

    Report

    Report Number
    2249697-2012-00777
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURER DATE FOR LOT MEPPL9: 12/04/2008. METHOD: REVIEW OF DEVICE HISTORY, COMPLAINT HISTORY. DEVICE HISTORY REVIEW INDICATED THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER REPORTED EVENTS FO A DISCOLORED OR TARNISHED FEMORAL HEADS. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SURGEON THOUGHT THE HEAD LOOKED DISCOLORED OR TARNISHED NOT QUITE POLISHED. OPENED SECOND 06-4010 MEPPL9. THOUGHT SAME PROBLEM MAYBE A LITTLE BETTER, PACKAGING SEEMED INTACT, EXPIRATION WAS CURRENT, OPENED THIRD AND USED. THE THIRD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 40MM/+10 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MKL7K7 AND MEPPL9

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other