BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21604280 · Received March 14, 2025

    Report

    Report Number
    3005180920-2025-00216
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 FEBRUARY 2025. LOT 2343334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23/01/2024. EXPIRATION DATE: 08/01/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 FEBRUARY 2025. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K121416) LOT. 2343139 LOT 2343139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13/02/2024. EXPIRATION DATE: 30/01/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0317FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM R (K121416) LOT. 2102167 LOT 2102167:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 07/04/2021. EXPIRATION DATE: 22/03/2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PATIENT MATCH PLANNING REVIEW: THE PLANNING HAS BEEN REVIEWED AND NO ANOMALIES WERE FOUND. EACH STEP WAS PERFORMED CORRECTLY AND ACCORDING TO THE SURGEON'S PREFERENCES. NEXTAR DATA ANALYSIS: PRELIMINARY ANALYSIS OF THE PROVIDED INFORMATION HAS CONFIRMED THAT THE TIBIA AND FEMUR WERE SUCCESSFULLY REGISTERED ON THE FIRST ATTEMPT. THE FEMUR DISTAL CUT WAS PLANNED TO BE 7 MM HIGH ON BOTH THE MEDIAL AND LATERAL SIDES, WITH 2.5° OF VAR/VAL AND 5.5° OF FLEXION. HOWEVER, THE EXECUTED CUT RECORDED BY NEXTAR WAS 6.5 MM ON THE MEDIAL SIDE AND 7.5 MM ON THE LATERAL SIDE, WITH 3.5° OF VAR/VAL AND 3° OF FLEXION. THE TIBIA CUT WAS PLANNED TO BE 8 MM HIGH ON BOTH THE MEDIAL AND LATERAL SIDES, WITH 2.5° OF VAR/VAL AND 5° OF THE POSTERIOR SLOPE. HOWEVER, THE EXECUTED CUT RECORDED BY NEXTAR WAS 7 MM ON BOTH THE MEDIAL AND LATERAL SIDES, WITH 2.5° OF VAR/VAL AND 4.5° OF FLEXION. THE QUALITY OF THE POSTOPERATIVE X-RAY IS TOO POOR TO MAKE AN ACCURATE ASSESSMENT, HOWEVER, THE CUTS DO NOT SEEM THAT FAR FROM NEUTRAL ALIGNMENT, THUS SUGGESTING THAT VALGUS COULD BE CAUSED BY AN EXTREMELY LOOSE MEDIAL COLLATERAL LIGAMENT. THIS IS ALSO CONFIRMED IN THE COMPLAINT ITSELF AND BY NEXTAR GRAPHS REPRESENTING THE PRE-OP LIGAMENTS CONDITION.

    Description of Event or Problem · 0

    PATIENT WAS OPERATED WITH GMK-SPHERE SYSTEM. DURING THE SURGERY, NEXTAR AND MYKNEE GUIDES WERE USED. PREOPERATIVELY SHE HAD A VARUS LEG AXIS, POSTOPERATIVELY SHE IS NOW VERY VALGUS. THE PATIENT IS IN REHABILITATION AND SHE IS DOING QUITE WELL. NO REVISION IS PLANNED. THE PATIENT IS MORE THAN 120 KG. THE SURGEON DID NOT PERFORM ANY FURTHER CUTS AFTER THE LAST SAVED CUTS ON NEXTAR PLATFORM. PATIENT'S LIGAMENTS CONDITION WAS VERY CRITICAL; THE PATIENT HAD A PREOPERATIVE STRETCH DEFICIT. THE VALGUS CONDITION WAS NOT NOTED INTRA-OPERATIVELY BECAUSE THE PATIENT HAD A VERY BIG SOFT TISSUE THEREFORE IT WAS NOT POSSIBLE TO SEE THE HKA AXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091164 GMK SPHERE TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R JWH MEDACTA INTERNATIONAL SA 02.12.0003R 2343334 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other