BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA CRVD GVF INS 4 10MM

    MDR report key: 1130978 · Received August 20, 2008

    Report

    Report Number
    1818910-2008-03244
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K033272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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

    PT WAS REVISED TO ADDRESS INFECTION. POLY ALSO SEEMS TO HAVE EARLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA CRVD GVF INS 4 10MM 87JWH JWH DEPUY ORTHOPAEDICS, INC., DEPUY RAYNHAM NA CS4FE4000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention