BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC KEEL TIB TRAY CEM SZ 5

    MDR report key: 1000399 · Received February 19, 2008

    Report

    Report Number
    1818910-2008-00398
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROX 14 YRS AGO. EXAMINATION WAS NOT POSSIBLE AS NO PROD WAS RETURNED. A SEARCH OF THE WARSAW AND INTL COMPLAINT DATABASE DID NOT FIND ANY ADD'L REPORTS OF THIS NATURE FOR THE PROD CODE/LOT PROVIDED SINCE ITS RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PROD FAILED TO MEET SPECS OR CONTRIBUTED TO THE REPORTED EVENT. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE TRAY AND FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC KEEL TIB TRAY CEM SZ 5 87JWH JWH DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 798AP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention