BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM RT SZ 3

    MDR report key: 1040134 · Received May 7, 2008

    Report

    Report Number
    1818910-2008-01406
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., RAYNHAM DIVISION
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS NO PRODUCT WAS RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WAS NOT PROVIDED. ALTHOUGH THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION, IT WOULD NOT BE UNREASONABLE TO EXPECT SOME WEAR AFTER APPROXIMATELY 9 YEARS OF IMPLANTATION. 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 POLY WEAR OF THE INSERT, OSTEOLYSIS, AND LOOSENING OF THE FEMORAL COMPONENT (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM RT SZ 3 87JWH JWH DEPUY ORTHOPAEDICS, INC., RAYNHAM DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention