BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 5162 · Received April 27, 1993

    Report

    Report Number
    5162
    Event Type
    Injury
    Date Received
    April 27, 1993
    Date of Event
    April 2, 1993
    Report Date
    April 6, 1993
    Manufacturer
    SMITH AND NEPHEW RICHARDS
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SINKING OF TIBIAL COMPONENT;LOOSENING OF ALL THREE COMPONENTS; LOW GRADE INFECTION;SGY REQUIRED TO REMOVE PROSTHESISDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS Implant TOTAL KNEE PROSTHESIS HSX SMITH AND NEPHEW RICHARDS 4X18867,3X71220,3X73430,2X0674

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention