BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLER-GALANTE TOTAL KNEE

    MDR report key: 1145 · Received August 24, 1992

    Report

    Report Number
    32821-1992-00002
    Event Type
    Injury
    Date Received
    August 24, 1992
    Date of Event
    August 6, 1992
    Report Date
    August 11, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD INDICATION OF PAIN AND SOME INSTABILITY. CHIPS OF ARTICULATING SURFACE WERE FOUND IN KNEE JOINT. ONLY ARTICULATING SURFACE WAS REPLACED IN THE SURGERY WITH THE SUBSTITUTE. THE REMAINDER OF THE IMPLANTS WERE LEFT UNTOUCHED IN THE PATIENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO 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 MILLER-GALANTE TOTAL KNEE Implant M/G I KRQ ZIMMER, INC. 63374100

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention