BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH & NEPHEW

    MDR report key: 2023579 · Received March 14, 2011

    Report

    Report Number
    MW5019830
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    November 17, 2010
    Report Date
    March 14, 2011
    Manufacturer
    SMITH & NEPHEW
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO PHYSICIAN'S OFFICE ON (B)(6) 2010 WITH COMPLAINT OF INSTABILITY OF RIGHT KNEE STATUS POST RIGHT KNEE REPLACEMENT IN (B)(6) 2009. FURTHER TESTING AS OP IN PHYSICIAN OFFICE REVEALED PCL DEFICIENT RIGHT TOTAL KNEE ARTHROPLASTY WITH RECURRENT JOINT STRAIN AND EFFUSIONS. PT UNDERWENT REVISION OF RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2010, WITH PREVIOUS IMPLANT REMOVED. PREVIOUS IMPLANT WAS (B)(6) TOTAL FEMUR SYSTEM. REASON GIVEN FOR REVISION WAS "RIGHT TKA FAILURE", "MODERATE MEDIAL-LATERAL INSTABILITY THROUGHOUT THE FULL RANGE OF MOTION." PT TOLERATED SURGERY WELL, AND WAS DISCHARGED HOME ON 3RD DAY POST-OP, WALKING WITH WALKER, WEIGHT BEARING AS TOLERATED, TO CONTINUE PHYSICAL THERAPY AT HOME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH & NEPHEW GENESIS II OXONIUM FEMUR SYSTEM MBH SMITH & NEPHEW 09BM11992

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| S