BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER, INC.

    MDR report key: 957 · Received July 27, 1992

    Report

    Report Number
    32474-1992-00001
    Event Type
    Malfunction
    Date Received
    July 27, 1992
    Report Date
    June 15, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DISLOCATION OF CUP LINER FROM SHELL, REPORTED BY SURGEON. EVENT TOOK PLACE WITH HIP DISLOCATION BY PATIENT WHILE EXCERCISING. A CLOSED REDUCTION WAS PERFORMED AT EMERGENCY MEDICAL FACILITY, IT IS NOT KNOWN WHETHER LINER DISASSOCIATED SECONDARY TO CLOSED REDUCTION, OR CAUSATIVE OF DISLOCATIONDEVICE 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: 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 ZIMMER, INC. Implant HARRIS GALANTE POROUS ACETABULAR CUP JDJ ZIMMER, INC. SIZE 54MM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other