BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    MDR report key: 16544211 · Received March 15, 2023

    Report

    Report Number
    3005180920-2023-00129
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 15, 2023
    Report Date
    March 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2023: LOT 2011077: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2021. EXPIRATION DATE: 2026-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.12.0314FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM (K1214169 R LOT. 1903265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT. 2101894: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2021. EXPIRATION DATE: 2026-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT 1 YEAR AND 7 MONTHS POST PRIMARY DUE TO INSTABILITY EXPERIENCED BY THE PATIENT DURING KNEE FLEXION. ALL DEVICES REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115089 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203R 2011077 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention