BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK PRODUCT - LEFT TOTAL HIP - CERAMIC

    MDR report key: 1250781 · Received December 1, 2008

    Report

    Report Number
    9616680-2008-00399
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 FROM THE PT. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT STATED THAT SHE IS EXPERIENCING A LOT OF SQUEAKING. WORSE IN CERTAIN POSITIONS, SUCH AS: CROUCHING OR BENDING KNEE. EXTREMELY LOUD WHEN WALKING UP AND DOWN STAIRS. ALSO, PT STATED THAT WHEN SHIFTING WEIGHT, SHE FEELS A SHUDDER OR CATCHING IN THE JOINT. PT IS NOT CURRENTLY EXPERIENCING ANY PAIN. SHE FEELS THE AUDIBLE NOISE IS GETTING WORSE THAN WHEN IT STARTED. HER ORTHO SURGEON AND A 2ND OPINION, BOTH DID EXTENSIVE X-RAYS AND FEEL IT IS SEATED EXTREMELY WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PRODUCT - LEFT TOTAL HIP - CERAMIC IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other