BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 3

    MDR report key: 1260012 · Received December 9, 2008

    Report

    Report Number
    1818910-2008-05607
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    DEPUY RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K032151
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RELEASED FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR CONTRIBUTION TO THE REPORTED PROBLEM. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PROD FAILED TO MEET SPECS OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, 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 TIBIAL LOOSENING WITH VARUS ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG MOD TIB TRAY CEM COCR 3 87JWH JWH DEPUY RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA Y66FG4000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention