BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 3 12.5

    MDR report key: 1250791 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05776
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    DEPUY CORK A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE MFG LOT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN. PROVIDED INFO STATED SYNOVITIS WAS REMOVED AND REVISION SURGERY DID NOT REVEAL ANY UNANTICIPATED POLYETHYLENE WEAR. INFECTION AFTER APPROX 1-1/2 YRS IMPLANTATION IS UNLIKELY TO BE PROD RELATED. NO EVIDENCE WAS FOUND SUGGESTING PROD ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS KNEE PAIN. SOME SYNOVITIS WAS REMOVED, AND SURGEON WENT AHEAD AND CHANGED THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 3 12.5 7NJL NJL DEPUY CORK A DIV OF DEPUY ORTHOPAEDICS, INC. NA 2346286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention