BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY INSERT

    MDR report key: 1181264 · Received September 29, 2008

    Report

    Report Number
    1818910-2008-04141
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED DEVICE LOOSENING OR POLYETHYLENE WEAR. PROVIDED INFORMATION INDICATED THE PATIENT LARGE PHYSICAL STATURE WAS A LIKELY CONTRIBUTING FACTOR TO THE DEVICE LOOSENING. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATING WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA. SOME EVIDENCE OF POLY PITTING WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY INSERT TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention