BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C.* FLUT TIB ROD 115X16MM

    MDR report key: 2981546 · Received February 27, 2013

    Report

    Report Number
    1818910-2013-02117
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 27, 2009
    Report Date
    May 21, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A P.F.C. SIGMA KNEE SYSTEM IN THEIR LEFT KNEE ON (B)(6) 2002. PATIENT SUFFERED FROM OSTEOLYSIS AND EARLY FAILURE OF HIS KNEE IMPLANT, WHICH REQUIRED A REVISION SURGERY ON (B)(6) 2007, REPLACING THE INSERT WITH A SIGMA CROSS-LINKED CURVED INSERT. PATIENT SUFFERED FROM OSTEOLYSIS AND EARLY FAILURE OF HIS KNEE IMPLANT AGAIN, WHICH REQUIRED A REVISION SURGERY ON (B)(6), 2009, REPLACING THE INSERT WITH ANOTHER DEPUY CROSS-LINKED CURVED INSERT. THEREAFTER, IN (B)(6) 2011, PATIENT RETURNED FOR FURTHER EVALUATION FOR OSTEOLYSIS, PAIN, AND FUNCTIONAL LIMITATION, AND WAS ADVISED THAT FURTHER REVISION SURGERY WAS NECESSARY, THOUGH THERE IS NO MENTION OF WHEN THAT SURGERY WILL BE. **UPDATE** (B)(6) 2013 - PATIENT'S REVISION OPERATIVE REPORTS RECEIVED (B)(6) 2012. ON (B)(6) 2007 REVISION SURGERY: PAINFUL LEFT TOTAL KNEE ARTHROPLASTY WITH LOOSENING OF LEFT TIBIAL PROSTHESIS. THE FOLLOWING WAS NOTED IN THE OPERATIVE REPORT: THE PATIENT WAS NOTED TO HAVE SOME ABUNDANT GRANULATION TISSUE WITHIN THE KNEE THAT APPEARED TO BE REACTIVE TISSUE SECONDARY TO EITHER POLYETHYLENE WEAR AND/OR LOOSENING OF THE TIBIAL COMPONENT; THE TIBIAL COMPONENT WAS GROSSLY LOOSE; THERE WAS FELT TO BE SIGNIFICANT BONE LOSS BONE MEDIALLY. TRAY AND CEMENT ADDED TO COMPLAINT. ON (B)(6) 2009 REVISION SURGERY: PAINFUL LEFT KNEE ARTHROPLASTY. TRAY AND STEM ADDED TO COMPLAINT. **UPDATE** (B)(6) 2013 - STICKER PAGE RECEIVED (B)(6) 2012 FOR (B)(6) 2002 PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84334 P.F.C.* FLUT TIB ROD 115X16MM TIBIAL ROD JWH DEPUY IRELAND 281088R

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention