BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R

    MDR report key: 18450040 · Received January 5, 2024

    Report

    Report Number
    3005180920-2023-01068
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 13, 2023
    Report Date
    January 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707626
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 DECEMBER 2023. LOT 2203225: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-APR-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 10MM INSERT WITH A 13MM INSERT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507092 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 2203225 07630040707626

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention