BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    MDR report key: 11973432 · Received June 10, 2021

    Report

    Report Number
    3005180920-2021-00472
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20.05.2021: LOT 168377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2017. EXPIRATION DATE: 2022-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 20.05.2021: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT. 170327 LOT 170327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2017. EXPIRATION DATE: 2022-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K121416) LOT. 168736 LOT 168736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-MAY-2017. EXPIRATION DATE: 2022-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    3 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY FIRST STAGE REVISION TOTAL KNEE WAS DONE DUE TO DIAGNOSED (B)(6) INFECTION 4 YEARS AFTER THE PRIMARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869516 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4R 168377 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention