BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J & J TRIAD

    MDR report key: 7466 · Received February 9, 1994

    Report

    Report Number
    7466
    Event Type
    Injury
    Date Received
    February 9, 1994
    Report Date
    August 19, 1993
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    GROSSLY LOOSE FEMORAL COMPONENT. INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J TRIAD Implant TOTAL HIP ROSTHETIC JDG JOHNSON & JOHNSON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention