BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM LINER MSER, 28MM, 20 DEG

    MDR report key: 1192021 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04365
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    DEPUY-RAYHAM, A DIVISON OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K924492
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION. THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR INSTABILITY, POLYETHYLENE WEAR NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM LINER MSER, 28MM, 20 DEG 87KWA KWA DEPUY-RAYHAM, A DIVISON OF DEPUY ORTHOPAEDICS, INC. NA SC106837

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention