BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOWMEDICA HARRIS HIP AND CUP

    MDR report key: 8368 · Received August 1, 1994

    Report

    Report Number
    37044-1994-09001
    Event Type
    Malfunction
    Date Received
    August 1, 1994
    Date of Event
    July 15, 1994
    Report Date
    July 22, 1994
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HIP PAIN RESULTING FROM LOOSENED IMPLANT. WAS REVISED USING HOWMEDICA HNR STEM AND CLUSTER SHELL.DEVICE 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 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: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOWMEDICA HARRIS HIP AND CUP Implant TOTAL HIP KWB HOWMEDICA, INC. 8T1157, AN7909

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other