BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY LCS COMPLETE PRIMARY FEMORAL

    MDR report key: 4190096 · Received October 15, 2014

    Report

    Report Number
    MW5038675
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    DEPUY
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE POLYETHYLENE PATELLA OF MY DEPUY TOTAL KNEE REPLACEMENT BROKE INTO 2 PIECES. THIS HAPPENED ONLY 8 YEARS ((B)(6) IT BROKE) AFTER THE SURGERY WITH NORMAL WEAR AND TEAR. THE PATELLA MARKERS WERE TRAVELING UP MY THIGH AND THE BROKEN PIECES FLOATED AROUND IN MY KNEE. WE WERE TOLD THIS KNEE COULD LAST UP TO 25 YEARS. DEPUY SAYS 15 YEARS OR MORE. HAD TO HAVE REVISION SURGERY WITH DIFFICULTY HEALING DUE TO REPEATED INCISIONS INTO SCAR TISSUE. THE PATELLA WAS REPLACED ANOTHER AND THE DOCTOR SAYS I'LL NEED TO FIND ANOTHER TOTAL REPLACEMENT WITHIN TEN YEARS DUE TO THIS "OUTDATED" KNEE. THE PARTS USED WERE DEPUY LCS COMPLETE PRIMARY FEMORAL #129403050 LOT# 1850620, LCS COMPLETE RP INSERT #1294-05-512 LOT #Y848L4000, MBT KEEL TIBIAL TRAY #129433150 LOT #1934302, LCS COMPLETE M/B PATELLA POROCOAT #1294-09-650 LOT #1951298 AND BONE CEMENT # 545031000. I WANT TO KNOW IF THERE IS A RECALL ON THE POLY PATELLA COMPONENT. THANK YOU. INFO STATED IN (B)(6) 2014: DR. REPORT AND REVISION SURGERY PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652677 DEPUY LCS COMPLETE PRIMARY FEMORAL FEMORAL KNEE COMPONENT JWH DEPUY 1850620
    652678 LCS COMPLETE RP INSERT RP INSERT JWH DEPUY 4848L4000
    652679 MBT KEEL TIBIAL TRAY KEEL TIBIAL TRAY JWH DEPUY 1934302
    652680 LCS COMPLETE M/B PATELLA PATELLA POROCOAT JWH DEPUY 1951298
    652681 BONE CEMENT BONE CEMENT LOD DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R| S