BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    MDR report key: 16240592 · Received January 25, 2023

    Report

    Report Number
    3005180920-2022-01005
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    September 29, 2016
    Report Date
    January 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 DECEMBER 2022: LOT 162463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2016. EXPIRATION DATE: 2021-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 29 DECEMBER 2022: GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT 162681: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUNE-2016. EXPIRATION DATE: 2021-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 58 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R (K121416) LOT 163068: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JULY-2016. EXPIRATION DATE: 2021-07-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INVESTIGATION PERFORMED BY MEDACTA R&D KNEE PROJECT MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT DUE TO INSTABILITY AFTER SIX YEARS FROM PRIMARY IMPLANTATION. SURGEONS TRIED TO INCREASE THE POLY HEIGHT BUT THAT WAS NOT SUFFICIENT TO SOLVE THE INSTABILITY. PRELIMINARY INVESTIGATION BASED ON THE PICTURES SENT OF THE EXPLANTED FEMUR, TIBIA AND INSERT. FROM PRELIMINARY INVESTIGATION WE CAN'T NOTICE ANY ANOMALIES THAT COULD HAVE PLAYED A ROLE IN THE EVENT. WE CAN SEE SOME DENTS AND SCRATCHES ON THE COMPONENTS MOST LIKELY CAUSED DURING THE REVISION SURGERY. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT WAS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT HAD AN INSTABILITY OF THE RIGHT KNEE. THE SURGEON TRIED TO INCREASE THE INLAY TO RESTORE THE REQUIRED STABILITY. HE DIDN´T ACHIEVE THIS STABILITY AND REVISED ALSO THE FEMUR AND TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175895 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203R 162463 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention