BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/R NPOR FEM RT SZ 3

    MDR report key: 1040127 · Received May 7, 2008

    Report

    Report Number
    1818910-2008-01452
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY-CORK DIVISION
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, INFORMATION PROVIDED IN THE INITIAL REPORT SUGGESTS THAT THE IMPLANT DESIGN CHOSEN FOR THE INITIAL SURGERY DID NOT ACHIEVE THE DESIRED RESULTS. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS REPORTED THAT THE PATIENT FELT HER KNEE "POP" DURING PHYSICIAN THERAPY APPROXIMATELY 2 WEEKS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/R NPOR FEM RT SZ 3 87JWH JWH DEPUY ORTHOPAEDICS, DEPUY-CORK DIVISION NA 2493057

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention