BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM RT SZ 4

    MDR report key: 1232257 · Received November 13, 2008

    Report

    Report Number
    1818910-2008-05096
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 AGAINST THE MANUFACTURING LOTS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING; HOWEVER, PROVIDED INFORMATION INDICATED THE PATIENT EXPERIENCED TRAUMA (FALL) PRIOR THE ONSET OF PROBLEMS. IN ADDITION, NO CONCLUSIONS COULD NOT BE DRAWN 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WS REVISED TO ADDRESS LOOSENING AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM RT SZ 4 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA HX74954G

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention