BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV DOME PAT 3 PEG,32

    MDR report key: 3040638 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15040
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POOR PATELLA TRACKING AND MISALIGNMENT OF THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143763 PFC*SIGMA/OV DOME PAT 3 PEG,32 PATELLA PROSTHESIS JWH 9616671 DEPUY (IRELAND) 2500780

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention