BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MOD DOME PATELLA 38MM

    MDR report key: 1864424 · Received October 6, 2010

    Report

    Report Number
    1818910-2010-07246
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROXIMATELY 14-1/2 YEARS PRIOR TO REVISION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR RESULTING IN METAL WEAR. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC MOD DOME PATELLA 38MM 87 JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 026126

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention