BEUDAMED
    FDA Adverse Event Injury Summary report: N

    64 BEADED PSL TYPE SHELL

    MDR report key: 1890012 · Received November 1, 2010

    Report

    Report Number
    2249697-2010-01438
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: MULTIPLE ATTEMPTS WERE MADE TO OBTAIN RELEVANT INFORMATION, BUT THE INFORMATION WAS NOT AVAILABLE. ALTHOUGH THERE WAS LIMITED INFORMATION PROVIDED TO STRYKER ORTHOPAEDICS, THE RESULTS OF THE INVESTIGATION PERFORMED SUGGEST THAT THE CAUSE OF THE POLYETHYLENE WEAR AND PAIN IS NOT DEVICE RELATED AS THE DEVICE EXPERIENCED NORMAL WEAR DURING DAILY ACTIVITIES THROUGHOUT THE 19 YEARS OF VIVO SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CUP AND LINER WERE REVISED DUE TO WEAR AND PAIN. NO IMPLANT CAT#S WERE AVAILABLE AND THERE ARE NO IMPLANTS TO SEND BACK DUE TO PATIENT WANTING TO KEEP THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 64 BEADED PSL TYPE SHELL IMPLANT KWB STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R