BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 799 · Received June 26, 1992

    Report

    Report Number
    799
    Event Type
    Malfunction
    Date Received
    June 26, 1992
    Date of Event
    June 9, 1992
    Report Date
    June 12, 1992
    Manufacturer
    MURRAY-SHAW KNEE
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    73 YEAR OLD MALE HAD A RIGHT MURRAY - SHAW KNEE REPLACED IN 1975 AT THE VA HOSPITAL IN SYRACUSE, N. Y. HE WAS SEEN BY AN ORTHOPEDIC SURGEON ON 5/11/92 FOR COMPLAINTS OF SWELLING AND INSTABILITY OF HIS RIGHT KNEE CAUSING INCREASED DISCOMFORT AND DIFFICULITY WITH MOBILITY. X-RAYS REVEALED LOOSE STAPLES IN THE KNEE AND EVIDENCE OF DAMAGE TO THE POLYETHYLENE. CASE WAS PRESENTED AT ORTHO CONFERENCE; REVISION ARTHROPLASTY RECOMMENDED. 6/9/92 HE UNDERWENT DEBRIDEMENT OF THE RIGHT KNEE, SYNOVECTOMY BY SHARP DISSECTION REMOVAL OF STAPLES, REMOVAL AND REPLACEMENT OF TIBIAL POLYETHELENE TRAY AND TIBIAL BOLT. THERE APPEARED TO BE A TREMENDOUS DEGREE OF CHRONICD REACTIVE SYNOVITIS. PHOTOGRAPHS WERE TAKEN. THE LOOSE AND BROKEN STAPLES AND SCREW WERE LOCATED AND REMOVED. THE POLYETHELENE SPACER WAS REMOVED AND REPLACED WITH A LARGER POLYETHELENE SPACER. THE MEDIAL COLLATERAL LIGAMENT WAS LARGELY DESTROYED BY THE CHRONIC INSTABILITY OF THE KNEE. THE MEDIAL CAPSULE WAS PARTIALLY DIVIDED ANTERIORLY AND REPAIRED TO THE PATELLAR TENDON IN THE MEDIAL MARGIN OF THE PATELLA IN A PANTS OVER VEST REPAIR TO PROVIDE ADDITIONAL SECURITY. FLEXION OF THE KNEE COULD BE ACCOMPLISHJED AND IT WAS SECURE IN EXTENSION. PATH REPORT ON PIECES OF SYNOVIAL TISSUE WAS CONSISTENT WITH CALCIUM PYROPHOSPHATE CRYSTALSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, UNANTICIPATED ADVERSE REACTION - LONG TERM, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant UNKNOWN JWH MURRAY-SHAW KNEE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other