BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA C-TAPER HEAD

    MDR report key: 1267831 · Received December 16, 2008

    Report

    Report Number
    9616680-2008-00424
    Event Type
    Other
    Date Received
    December 16, 2008
    Date of Event
    December 1, 2008
    Report Date
    December 1, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWY
    PMA / PMN Number
    K051588
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "OFF LABEL USE OF A CERAMIC C-TAPER BIOLOX DELTA HEAD. SURGEON PUT IT ON TO A DIFFERENT MANUFACTURER TAPER. SURGEON WAS NOTIFIED AT THE TIME OF IMPLANTATION THAT THERE WAS A RISK OF FRACTURE AND THAT IT WAS OFF LABEL AND RISK OF TAPER DISENGAGING AND NOT SEATING PROPERLY. TAPER DID APPEARED TO LOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA C-TAPER HEAD IMPLANT KWY STRYKER ORTHOPAEDICS NA 102636030

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other