BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA OV DOME PAT 3PEG 41

    MDR report key: 3133164 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17729
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PATIENT X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT AW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE DEVICE AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE HIS PATELLA WASN'T TRACKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235325 PFC SIGMA OV DOME PAT 3PEG 41 PATELLA PROSTHESIS JWH 9616671 DEPUY (IRELAND) 3425212

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention