BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN ALLPOLY TIB LM/RL S4 7MM

    MDR report key: 2852295 · Received November 30, 2012

    Report

    Report Number
    1818910-2012-28433
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN, INSTABILITY, AND POLY WEAR OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN ALLPOLY TIB LM/RL S4 7MM ALL POLY TIBIAL HRY DEPUY INTERNATIONAL YEU22

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention