BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM LT SZ 5

    MDR report key: 1233611 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-05074
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K971189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE STERILE CERTIFICATIONS FOR THE PRODUCT CODE/LOTS PROVIDED DID NOT REVEAL ANY DEVIATIONS OR ANOMALIES AND ALL PRODUCT WAS CERTIFIED STERILE PRIOR TO RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM LT SZ 5 87JWH JWH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA HX81945B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention