BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 15064777 · Received July 20, 2022

    Report

    Report Number
    3005180920-2022-00532
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    June 21, 2022
    Report Date
    August 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 JUNE 2022: LOT 141808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2014. EXPIRATION DATE: 2019-APR-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. CONSIDERING THE LOT OF THE SCREW - REF. 75.16.291 LOT. 141657: LOT 141657: (B)(4) ITEMS MANUFACTURED AND 123 LOTS MANUFACTURED WITH THIS SEMIFINISHED. 8 OUT OF 123 LOTS ARE INVOLVED IN COMPLAINTS FOR UNSCREWING: 10 COMPLAINTS IN TOTAL (2 LOTS ARE INVOLVED IN 2 COMPLAINTS). ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 22 JUNE 2022: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 144874: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2014. EXPIRATION DATE: 2019-JUNE-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL DIRECTOR: AT ABOUT 7 YEARS AFTER PRIMARY CEMENTED TKA, THE PATIENT FEELS INSTABILITY AND THE XRAY EXAMINATION SHOWS A DISLODGED INSERT FIXATION SCREW AND PROBABLY A MOBILIZED TIBIAL TRAY. THE SCREW IS FAR AWAY FROM ARTICULATING AREAS; THERE IS NO MENTION, IN THE REPORT, OF DAMAGES ASCERTAINED DURING REVISION SURGERY TO THE ARTICULATING SURFACES OF THE FEMORAL COMPONENT. THE REPORT ALSO MENTIONS EASY DETACHMENT OF THE TIBIAL TRAY FROM THE CEMENT MANTLE: THE CLINICAL RELEVANCE OF THIS FINDING IS NOT DETERMINED IN THE REPORT. NORMALLY, THIS CONDITION OCCURS WHEN A CEMENTATION PROBLEM HAS OCCURRED. 7 YEARS IS AN UNUSUAL TIME BOTH FOR THE SELF-UNSCREWING OF THE INSERT SCREW AND FOR THE METAL DEBONDING FROM CEMENT. FROM PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D KNEE MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 7 YEARS FROM PRIMARY IMPLANTATION DUE TO TIBIA LOOSENING. PRE-REVISION X-RAYS SHOWED THAT THE TIBIAL INSERT SECURE SCREW WAS LOOSENED IN THE JOINT. THE PICTURE SENT FOR INVESTIGATION SHOWS THAT THE TIBIAL COMPONENTS (TRAY AND INSERT) HAVE BEEN REMOVED AND THE CEMENT REMAINED ADHERENT TO THE BONE. REASONS FOR LOOSENING ARE MOST LIKELY RELATED TO CEMENT AND CEMENTATION PROBLEM AND NOT TO THE IMPLANT. LOOSENING OF THE SECURE SCREW WAS PROBABLY CAUSED BY INSUFFICIENT TIGHTENING TORQUE APPLIED TO THE SCREW AT THE TIME OF PRIMARY IMPLANTATION. A TORQUE LIMITING SCREWDRIVER, NOT AVAILABLE AT THE TIME OF THE PRIMARY SURGERY, IS CURRENTLY AVAILABLE AND MANDATORY TO LOCK THE SECURE SCREW. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO AN IMPLANT FAILURE.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 7 YEARS FROM PRIMARY IMPLANTATION DUE TO TIBIA LOOSENING AND FIXATION SCREW LOOSENING. ON THE ARTICULAR SURFACE OF THE TIBIAL INSERT, IT IS POSSIBLE TO NOTE DEEP SCRATCHES ON BOTH THE LATERAL SIDE AND CENTRAL AREA. THESE SIGNS ARE COMPATIBLE WITH THE FIXATION SCREW, WHICH, ONCE BECOME LOOSE, IT IS POSSIBLE TO SUPPOSE THAT IT HAS BEEN POSITIONED IN THE JOINT SPACE AND MAY HAVE GENERATED THOSE GROOVES AND SCRATCHES. THE MOST LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW IS INSUFFICIENT TIGHTENING TORQUE. A TORQUE LIMITING SCREWDRIVER, NOT AVAILABLE AT THE TIME OF THE PRIMARY SURGERY, IS CURRENTLY AVAILABLE AND MANDATORY TO LOCK THE SECURE SCREW. NO CEMENT IS PRESENT ON THE BOTTOM SURFACE OF THE EXPLANTED TIBIAL TRAY. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT CAN BE RELATED TO MULTIPLE FACTORS, MOST LIKELY NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, TIME, AND PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE). THE LACK OF CEMENT ADHERING TO THE DEVICE IS NOT EVIDENCE OF A FAULTY DEVICE. NO OTHER ELEMENTS RELEVANT TO THE EVENT CAN BE NOTED FROM VISUAL INSPECTION.

    Description of Event or Problem · 0

    DURING A FOLLOW-UP VISIT, IT WAS NOTED FROM THE XRAYS THAT THE SCREW OF THE INSERT HAD COME OUT. AT 7 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE REVISION SURGERY WAS PERFORMED AND DURING THE REVISION IT WAS ALSO NOTED THAT THE TIBIAL TRAY WAS LOOSENED AND THAT NO CEMENT WAS PRESENT ON THE IMPLANT. IT IS UNKNOWN IF THE SURGEON USED A TORQUE-LIMITING SCREWDRIVER DURING THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899081 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 141808 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention