BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM ELBOW V

    MDR report key: 7041 · Received November 10, 1993

    Report

    Report Number
    33448-1993-00141
    Event Type
    Injury
    Date Received
    November 10, 1993
    Date of Event
    September 15, 1993
    Report Date
    October 4, 1993
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    KWJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CHRONIC DISLOCATION AND DEEP WOUND INFECTION. ALL IMPLANTS REMOVED. FAIR.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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ELBOW V Implant SOUTER CUSTOM ELBOW KWJ HOWMEDICA, INC. LZPZD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention