BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 2240568 · Received September 9, 2011

    Report

    Report Number
    8010764-2011-00023
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 9, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MINIMAL WEAR WAS OBSERVED IN THE PROXIMAL ARTICULATING AREAS AND GOUGING AND WEAR WERE FOUND ON THE DISTAL SURFACE OF THE INSERT. THE GOUGING AND WEAR ON THE DISTAL SURFACE INDICATES THE PATIENT WAS LOADING THE INSERT WHILE IT WAS DISLOCATED. ADDITIONALLY, THE ANTERIOR LOCK DID NOT SHOW ROUNDING OF THE CORNERS WHICH INDICATES THAT THE INSERT WAS NOT FULLY LOCKED. A FULLY LOCKED INSERT WOULD TYPICALLY SHOW MILD ROUNDING IN THE AREAS WHERE THE INSERT ENGAGES THE TIBIAL TRAY ANTERIOR LOCKING MECHANISM. DAMAGE WAS ALSO OBSERVED ON THE INFERIOR SURFACE OF THE POSTERIOR LOCKING MECHANISM INDICATING THAT THE LOCKING MECHANISM HAD BEEN RIDING ON THE TIBIAL TRAY LOCKING MECHANISM. DIMENSIONAL MISMATCH BETWEEN THE TIBIAL INSERT AND TIBIAL BASE IS ONE OF THE IMPORTANT FACTORS CONTRIBUTING TO THE IMPROPER SEATING OF THE INSERT. THE CONTRIBUTION OF THE TIBIAL BASE TO THIS ISSUE IS UNKNOWN AS IT WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WAS NOT LOCKED AND THAT REVISION SURGERY WAS REQUIRED TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS GII PS INSERT SZ 3-4 11MM JWH SMITH & NEPHEW, INC. 11ET06321

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention