BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ3 10MM

    MDR report key: 1090123 · Received July 30, 2008

    Report

    Report Number
    1818910-2008-03029
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY CORK
    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

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. 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 ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY. POLY WEAR WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSERT SZ3 10MM 87JWH JWH DEPUY ORTHOPAEDICS, DEPUY CORK NA 1055703

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention