BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23121613 · Received September 23, 2025

    Report

    Report Number
    3005180920-2025-00887
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2025. GMK-SPHERE 02.12.0005L SPHERE FEMUR CEMENTED LEFT S5 ( K121416 ) LOT. 1903603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-AUG-2019. EXPIRATION DATE: 2024-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0412FL GMK-SPHERE TIBIAL INSERT - FLEX S4L - 12 MM (K121416) LOT. 1902478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUNE-2019. EXPIRATION DATE: 2024-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.T3I4L GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L ( K121416 ) LOT. 1902452: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2019. EXPIRATION DATE: 2024-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE REPORTED CAUSE WAS METAL ALLERGY WITH NO ALLEGED DEVICE DEFICIENCY OR CONTRIBUTING FACTOR, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS 5 MONTHS, THE PATIENT CAME IN DUE TO LACK OF MOBILITY AS A RESULT OF TIGHTNESS. THE CAUSE WAS DETERMINED BY THE SURGEON TO BE THE RESULT OF A NICKEL ALLERGY. THE SURGEON REVISED ALL COMPONENTS TO A SENSITIN REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196245 GMK SPHERE TOTAL KNEE SYSTEM SPHERE FEMUR CEMENTED LEFT S5 JWH MEDACTA INTERNATIONAL SA 02.12.0005L 1903603

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention