BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP CONDYLAR PLATE 8 HOLES/206MM-LEFT

    MDR report key: 1820586 · Received August 26, 2010

    Report

    Report Number
    3003506883-2010-00044
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    November 5, 2009
    Report Date
    August 4, 2010
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS FOR THIS LOT NUMBER HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A PT SUFFERED A PATHOLOGIC SUBACUTE NONDISPLACED COMMINUTED FRACTURE OF THE DISTAL L FEMORAL METAPHYSIS, EXTENDING TRANSVERSELY THROUGH THE DISTAL FEMORAL DIAPHYSIS AND VERTICALLY THROUGH THE INTERCONDYLAR NOTCH INTO THE TIBIOFEMORAL JOINT. SHE HAD A SMALL MEDIALLY DISPLACED FRACTURE FRAGMENT ORIGINATING FROM THE MEDICAL ASPECT OF THE DISTAL FEMORAL METADIAPHYSIS WITH SURROUNDING CALLUS FORMATION. PT HAD OSTEOPENIA IN THE SAME LEG AND ARTHRITIS ALONG WITH A BONE SPUR. PT TREATED WITH A BRACE. APPROX 6 WEEKS LATER, PLATE WAS IMPLANTED. PT TOLD TO BE NWB FOR 3 MOS. ON FOLLOW-UP PT WAS TOLD TO BE WBAT. THE NEXT DAY, PT HAD PAIN AND SWELLING AND AN X-RAY SHOWED THE PLATE BROKEN. PT WAS REVISED TO A COMPETITORS REAMED NAIL WITH BONE PUTTY, AUTOGRAFT AND AN INTERNAL BONE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP CONDYLAR PLATE 8 HOLES/206MM-LEFT LCP CONDYLAR PLATES HRS SYNTHES ELMIRA NA 6108763

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCREWS