BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC OVPAT35MM SM

    MDR report key: 2073556 · Received April 26, 2011

    Report

    Report Number
    1818910-2011-07248
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K935262
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROXIMATELY SIXTEEN 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED DUE TO LOOSENING OF THE PATELLA COMPONENT AT THE BONE/CEMENT INTERFACE. REVISION SURGERY FOUND THE PATELLA PEGS HAD SHEARED OFF. POLY WEAR OF THE TIBIAL INSERT WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC OVPAT35MM SM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 061088

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention