BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATELLOFEMORAL JOINT REPLACEMENT

    MDR report key: 5597642 · Received April 19, 2016

    Report

    Report Number
    MW5061828
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    November 10, 2015
    Report Date
    April 19, 2016
    Manufacturer
    DEPUY
    Product Code
    OIY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REQUIRED PFJ REPLACEMENT IN PART OF RECONSTRUCTIVE SURGERY IN (B)(6) 2009 AFTER SUSTAINING INJURY TO KNEE. I DO STILL HAVE PAIN AS A RESULT OF THE INJURY AND DEVELOPMENT OF RSD/CRPS DISEASE. I AM NOT ABLE TO BEAR WEIGHT OR DO ANYTHING SUCH AS RUNNING, CYCLING, ETC THAT WOULD ULTIMATELY STRESS THIS JOINT. IT IS IN THE NON-WEIGHT BEARING AREA OF THIS YOUNG KNEE REPLACEMENT. AT F/U APPT WITH ORTHOPEDIC SURGEON IN (B)(6) 2015, IT WAS DISCOVERED THAT IMPLANT COMPONENTS ARE LOOSENING. SO, I AM NOW REQUIRING ADD'L REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242376 PATELLOFEMORAL JOINT REPLACEMENT PATELLOFEMORAL JOINT REPLACEMENT OIY DEPUY 1180-02-050 CR9DB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R| S