BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM INS M28 10DEG 28MM 3MM L

    MDR report key: 1130975 · Received August 20, 2008

    Report

    Report Number
    1818910-2008-03394
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    September 26, 2007
    Report Date
    July 22, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K924492
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PROD AND LOT CODE SINCE THEIR RELEASE FOR DISTRIBUTION. ALTHOUGH UNAVAILABLE FOR EVAL, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROX 15.5 YRS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR WITH REGARD TO THE REPORTED EVENT BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PT WAS REVISED BECAUSE OF POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM INS M28 10DEG 28MM 3MM L 87KWA KWA DEPUY ORTHOPAEDICS, INC. NA SO29007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention