BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CUP

    MDR report key: 1062478 · Received June 17, 2008

    Report

    Report Number
    1818910-2008-02452
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE PART AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WERE NOT PROVIDED. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCTS AND/OR ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS POLYETHYLENE WEAR AND LOOSENING OF THE METAGLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY CUP TOTAL EXTREMITY REPLACEMENT KWB DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention