BEUDAMED
    FDA Adverse Event Other Summary report: N

    LCS ROT PLAT BRNG STD/10MM

    MDR report key: 812807 · Received January 8, 2007

    Report

    Report Number
    1818910-2006-04335
    Event Type
    Other
    Date Received
    January 8, 2007
    Report Date
    December 18, 2006
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    HRY
    PMA / PMN Number
    K821254
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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. KP830055.

    Description of Event or Problem · 1

    PT BELIEVES THIS DEVICE MAY HAVE BEEN RECALLED. SIX WEEKS POST OP WAS DETERMINED BY X RAY THAT UNCEMENTED TIBIAL COMPONENT FAILED TO BOND TO THE BOND AND HAD SUBSIDED INTO THE TIBIA. REVISION SURGERY ON HOLD. NEW ETQ RECORD CREATED IN ORDER TO UPDATE VIGILARE WATCH (LEGACY SYSTEM) COMPLAINT NUMBER. HAVE RECEIVED ADD'L PRODUCT INFO (IE BEARING) SEE PREVIOUS COMPLAINT RECORD FOR DETAILS (IE TIBIAL TRAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS ROT PLAT BRNG STD/10MM 87NJL HRY DEPUY INTERNATIONAL, LTD. NA S48D91020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA