BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1095394 · Received August 1, 2008

    Report

    Report Number
    3003506883-2008-00012
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 3, 2008
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PT UNDERWENT TOTAL KNEE REPLACEMENT RIGHT KNEE. ON POD#2 PT FELL AND SUSTAINED A CLOSED RIGHT FEMUR SUPERCONDYLAR FX. PT UNDERWENT ORIF WITH SUBJECT PLATE. PT WAS TTWB/NWB POST OP X 6 WEEKS, STARTED PWB. PT TWISTED KNEE AND FELT A 'POP'. DURING REVISION PROCEDURE, PLATE WAS NOTED AS BROKEN AT TRANSITION AREA BETWEEN PERIARTICULAR LOCKING HOLES AND SHAFT SCREWS. INTER-OP CULTURES TAKEN WERE POSITIVE FOR COAGULASE NEGATIVE STAPH AUREUS, AND A FEW NECROTIC BONE FRAGMENTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP CONDYLAR PLATE 8 HOLES/206MM-RIGHT LCP CONDYLAR PLATE HRS SYNTHES ELMIRA NA 5659664

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention ALLOGRAFT| SCREWS| DBX