BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL CEMENT PLUG

    MDR report key: 1981 · Received December 24, 1992

    Report

    Report Number
    33098-1992-00002
    Event Type
    Death
    Date Received
    December 24, 1992
    Date of Event
    December 2, 1992
    Report Date
    December 8, 1992
    Manufacturer
    BIODYNAMICS
    Product Code
    MJW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TOTAL HIP REPLACEMENT - LEFT HIP.PROBLEM AS PER INFORMANT: PATIENT DEATH POSSIBLY RERLATED TO AIR EMBOLUSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL CEMENT PLUG MJW BIODYNAMICS 16611

    Patients

    Seq Age Sex Outcome Treatment
    1 Death