BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

    MDR report key: 16768424 · Received April 19, 2023

    Report

    Report Number
    3005180920-2023-00251
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819940
    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 22 MARCH 2023: LOT 2002938: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUNE-2020. EXPIRATION DATE: 2025-06-15. 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 2 YEARS FROM PRIMARY IMPLANTATION FOR LOOSENING. FROM THE PICTURE OF THE EXPLANTED COMPONENTS, NO ANOMALIES CAN BE NOTED. WE CAN SEE THAT THE CEMENT REMAINED ADHERENT TO THE BONE. POOR INTERDIGITATION BETWEEN IMPLANTS AND CEMENT CAN HAVE VARIUOS ORIGINS, MOST LIKELY RELATED TO THE CEMENTATION PROCESS OR THE CEMENT ITSELF. FROM INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO FAULTY DEVICES. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0026L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ L (K140826) LOT 2003221: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2020. EXPIRATION DATE: 2025-06-25. 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 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 2008651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2020. EXPIRATION DATE: 2025-09-08. 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

    THE PATIENT CAME IN REPORTING REPORTED KNEE PAIN. THE SURGEON ORDERED A CT SCAN WHICH APPEARED THE COMPONENTS WERE LOOSE. WHILE PERFORMING THE REVISION, IT WAS CONFIRMED THAT ALL THREE CEMENTED COMPONENTS WERE LOOSE (TIBIA, FEMUR AND PATELLA). AT ABOUT 2 YEARS FROM PRIMARY THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273313 GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1206L 2002938 07630030819940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention