BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ5 8MM

    MDR report key: 1933577 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-10163
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR OF THE INSERT AND PATELLA, OSTEOLYSIS, AND LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT/IMPLANT INTERFACE (DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSERT SZ5 8MM 87JWH JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC. NA 68255A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention