BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA MOD TIB TRAY CEM SZ2

    MDR report key: 1260026 · Received December 9, 2008

    Report

    Report Number
    1818910-2008-05849
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INSERT PRODUCT CODE/LOT PROVIDED SINCE ITS RESPECTIVE RELEASE FOR DISTRIBUTION. THE ROOT CAUSE COULD NOT BE DETERMINED. NO EVIDENCE WAS FOUND THAT WOULD SUGGEST PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION WAS 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 REVISED TO ADDRESS SUBSIDED TIBIAL COMPONENT, MINIMAL POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA MOD TIB TRAY CEM SZ2 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention