BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD

    MDR report key: 7863 · Received March 31, 1994

    Report

    Report Number
    33462-1993-01150
    Event Type
    Injury
    Date Received
    March 31, 1994
    Date of Event
    February 22, 1994
    Report Date
    March 7, 1994
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    JDD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SURGEON REMOVED AND REPLACED WITH ANOTHER FEMORAL HEAD.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD Implant FEMORAL HEAD JDD HOWMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention