BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER COCR LFIT HEAD 26MM/0

    MDR report key: 1621879 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00967
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    December 30, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K910988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (FOREIGN MATTER FOUND IN THE PACKAGE OR ON THE DEVICE) AND PRODUCT CODE JDI.

    Description of Event or Problem · 1

    DIMENSIONAL DISCREPANCY. IT WAS REPORTED THAT, "BIOPOLAR HIP. SURGEON ASSEMBLED UNIVERSAL HEAD WITH C-TAPER HEAD, PLACED IT INTO THE STEM. HE NOTICED THAT THE HEAD WAS LOOSE AROUND THE NECK OF THE STEM. TOOK THE UNIVERSAL HEAD A PART FROM C-TAPER HEAD. TRIED THE C-TAPER HEAD BY ITSELF ON THE NECK OF THE STEM, AGAIN THE HEAD TOTALLY SPUN AROUND THE NECK. OPENED ANOTHER HEAD FROM DIFFERENT LOT # AND IT FIT PERFECTLY. ALSO TRIED THE HEAD ON NECK TRIALS, ALSO SPUN AROUND THE TRIALS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 26MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS NA DAHMRD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other