BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ4 10MM

    MDR report key: 1003972 · Received February 22, 2008

    Report

    Report Number
    1818910-2008-00529
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    DEPUY-RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS FOR THE MFG LOTS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED FRACTURED DEVICE. PROVIDED INFO INDICATED THE PT EXPERIENCED TRAUMA (FALL), WHICH COULD HAVE BEEN A POSSIBLE CONTRIBUTING FACTOR. 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 PRODUCTS AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS PAIN, FOUND PATELLA FRACTURED AT PEGS AND POLYETHYLENE WEAR ON INSERT. PT HAD A FALL APPROX ONE YEAR PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSERT SZ4 10MM 87JWH JWH DEPUY-RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 42680A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention