BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 21364697 · Received February 12, 2025

    Report

    Report Number
    3005180920-2025-00080
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    January 20, 2025
    Report Date
    February 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-JAN-2025: LOT 2111931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2022. EXPIRATION DATE: 15-DEC-2026. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0024R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R (K140826) LOT 2114604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2021. EXPIRATION DATE: 21-NOV-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0414FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R (K121416) LOT 180410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 26-APR-2023. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK-HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966210 GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R JWH MEDACTA INTERNATIONAL SA 02.07.1204R 2111931 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention