BEUDAMED
    FDA Adverse Event Injury Summary report: N

    44MM AUSTIN MOORE PROSTHESIS

    MDR report key: 8051 · Received March 3, 1994

    Report

    Report Number
    33462-1993-01142
    Event Type
    Injury
    Date Received
    March 3, 1994
    Date of Event
    January 25, 1994
    Report Date
    January 25, 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 IMPLANT AND REPLACED WITH CEMENTED #3 HIP FRACTURE STEM 32-3 HEAD/46MM PREMISE CUP.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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 44MM AUSTIN MOORE PROSTHESIS Implant FIXED HEAD ENDOPROSTHESIS JDD HOWMEDICA, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention