BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 1493 · Received September 26, 1992

    Report

    Report Number
    32966-1992-00005
    Event Type
    Injury
    Date Received
    September 26, 1992
    Report Date
    August 26, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT PREVIOUSLY HAD 9/64" THREADED STEINMAN PIN IMPLANTED FOR REPAIR OF FRACTURED RIGHT SHOULDER. SALESMAN WAS INFORMED THAT STEINMAN PIN HAD BROKEN AFTER SURGERY. SURGERY WAS AGAIN PERFORMED ON 8/11/92 BY DR. TO RETREIVE BROKEN PIN AND REPAIR FRACTURE. BROKEN STEINMAN PIN RETURNED TO ZIMMER, INCDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE 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: MAYBE. 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 ZIMMER, INC. Implant STEINMAN PIN - 9/64", THREADED JDW ZIMMER, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention