BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT

    MDR report key: 2233975 · Received August 31, 2011

    Report

    Report Number
    9610726-2011-00305
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    July 10, 2008
    Report Date
    August 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CLINICAL RESEARCHER REPORTED THE FOLLOWING, "(B)(6) 2008; PRIMARY RIGHT TOTAL KNEE REPLACEMENT FOR TRICOMPARTMENTAL OSTEOARTHRITIS. POST OPERATIVE NOTES ADVISED: CONTINUOUS PASSIVE MOTION MACHINE TO BE APPLIED AS THE PATIENT WAS REGARDED TO BE AT HIGH RISK OF STIFFNESS. PATIENT REMAINED IN HOSPITAL FOR 15 DAYS REQUIRING INTENSIVE PHYSIOTHERAPY TO ACHIEVE AN ADEQUATE RANGE OF MOTION FOR DISCHARGE. ON (B)(6) 2008: EXAMINATION UNDER ANAESTHETIC AND POSSIBLE INJECTION OF LOCAL ANAESTHESIA FOR POST-OP STIFFNESS SECONDARY TO ARTHROFIBROSIS. MANIPULATION UNDER ANAESTHETIC ACHIEVED 5-120 DEGREES RANGE OF MOVEMENT (ROM). PHYSIOTHERAPY ON DISCHARGE. ON (B)(6) 2008: ORTHOPAEDIC CLINIC: ROM = 10-95 DEGREES MEASURED. PATIENT REPORTED 105 DEGREES FLEXION ACHIEVED IN PHYSIOTHERAPY. ON (B)(6) 2008: ORTHOPAEDIC CLINIC: ROM = 5 - 105 DEGREES. RECEIVING HYDROTHERAPY AND PHYSIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SHYRM

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other