BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT LEFT HIP

    MDR report key: 1070410 · Received June 30, 2008

    Report

    Report Number
    2249697-2008-00185
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    STRYKER ORTHOPAEDIC MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DEVICE IS STILL IMPLANTED IN PATIENT AND THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT CALLED STRYKER TO ASK IF STRYKER IS DEALING DIRECTLY WITH PATIENTS WHO CLAIM THEY HAVE A "FAILED HIP" OR DO THEY HAVE TO GO THROUGH A LAWYER. PATIENT CLAIMS SHE LOST EXTERNAL ROTATION AND HAS NEVER GOTTEN IT BACK. SAYS SHE SAW TWO EXPERTS WHO TOLD HER, THERE IS SOMETHING WRONG WITH THE LINER. PATIENT DID NOT WANT TO SUBMIT A PER AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT LEFT HIP IMPLANT KWB STRYKER ORTHOPAEDIC MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other