BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22749124 · Received August 8, 2025

    Report

    Report Number
    3005180920-2025-00782
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862373
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JULY 2025. GMK-SPHERE 02.12.0023L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+L (K140826) LOT. 188920: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JAN 2018. EXPIRATION DATE: 17 DEC 2023. 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. ADDITIONAL DEVICES ALSO REVISED: GMK-SPHERE 02.12.0310FL GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM (K121416) LOT. 180372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2018. EXPIRATION DATE: 06 MAY 2023. 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 02.07.0034RP PATELLA RESURFACING S.2 (NEW GENERATION) (K090988) LOT. 1900601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MAY 2019. EXPIRATION DATE: 21 APRIL 2024. NO ANOMALIES WERE 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. CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    6 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED STIFFNESS WITH ONLY A 3° RANGE OF MOTION. THE SURGEON PERFORMED SOFT TISSUE RELEASES, DOWNSIZED THE FEMUR BY TWO SIZES, AND REVISED THE INSERT (WITH ONE OF THE SAME SIZE) AND PATELLA DUE TO TRACKING ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO MEDACTA PRODUCT ISSUE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999386 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+L JWH MEDACTA INTERNATIONAL SA 02.12.0023L 188920 07630030862373

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention