BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

    MDR report key: 8416474 · Received March 13, 2019

    Report

    Report Number
    3005180920-2019-00154
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827167
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 MARCH 2019: LOT 180380: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 2023-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ONE OF THE SURGEON TECH MADE A MISTAKE IN A SURGERY BY GIVING THE SURGEON A TIBIAL COMPONENT T4-I3 FOR FEMORAL COMPONENT 4. THE PATIENT HAS BEEN INFORMED TO HAVE A TIBIAL COMPONENT T4-I3, INSERT 3 AND FEMORAL COMPONENT 4. THE SURGEON WILL FOLLOW THE PROGRESSION OF THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210321 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 180380 07630030827167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other