BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV DOME PAT 3 PEG,32

    MDR report key: 3041960 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-15088
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. 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.

    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 TO ADDRESS SUBSIDENCE OF THE TIBIAL TRAY, POLY WEAR OF THE PATELLA, AND OSTEOLYSIS. LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE WAS ALSO REPORTED, WITH DEPUY CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION; HOWEVER, IT WAS REPORTED THAT THE PATIENT HAD FALLEN NUMEROUS TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146253 PFC*SIGMA/OV DOME PAT 3 PEG,32 PATELLA PROSTHESIS JWH DEPUY (IRELAND) 9616671 2139746

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention