BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,41

    MDR report key: 3874161 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21039
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE OF POLY WEAR AND LESIONS IN THE POSTERIOR CONDYLES, BOTH MEDIAL AND LATERAL. CLINICAL DER WAS ALSO RECEIVED, GROUP: DOTS. ADDITIONALLY, OSTEOLYSIS WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352604 PFC*SIGMA/OV/DOME PAT 3PEG,41 KNEE PATELLAR COMPONENT JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 160825

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention