BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER COCR LFIT HEAD 26MM/0

    MDR report key: 1846486 · Received September 27, 2010

    Report

    Report Number
    2249697-2010-01264
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K910988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: THE REPORTED EVENT COULD NOT BE CONFIRMED. DIMENSIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE RESULTS INDICATE THAT THE DEVICE WAS WITHIN THE MANUFACTURING SPECIFICATIONS. A FUNCTIONAL TEST WAS PERFORMED WITH THE RETURNED DEVICE AND THE OMNIFIT HFX 132 DEGREE CEMENTED FEMORAL HIP STEM RETRIEVED FROM INVENTORY. THE DEVICES FUNCTIONED AS INTENDED AND THE FEMORAL HEAD COULD NOT BE REMOVED FROM THE HIP STEM. DEVICE HISTORY RECORDS WERE REVIEWED. THE RESULTS INDICATE THAT THE DEVICES WERE WITHIN THEIR MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "SURGEON IMPLANTED OMI-FIT HFX PRESSFIT STEM, AND A # 9 C-TAPER. HE THEN IMPLANTED 26MM, 0 C-TAPER LFIT HEAD. THE 26MM, 0 C-TAPER DID NOT ENGAGE ON STEM TRUNNION. THE SURGEON WENT TO THE NEXT SIZE, 26MM +5 WHICH ENGAGED PROPERLY TO THE EXCISING TRUNNION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 26MM/0 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJJ870

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention