BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23436205 · Received October 31, 2025

    Report

    Report Number
    3005180920-2025-01048
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262003
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 14 OCTOBER 2025: GMK-SPHERE 02.12.E0510FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 10MM (K202022) LOT 2310265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUN-2023. EXPIRATION DATE: 2028-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.15.E035 MOTO PATELLA E-CROSS Ø35 (K213071) LOT 2238173: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2022. EXPIRATION DATE: 2027-10-27. 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. CONCLUSIONS: THE SURGEON REVISED LINER AND REMOVED SOME OSTEOPHYTES, TO RESTORE THE JOINT FROM FLEXION CONTRACTURE, STIFNESS. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN AND CAUSE IS UNKNOWN. THE SURGEON DETERMINED THE PATIENT HAD A SLIGHT FLEXION CONTRACTURE. AT ABOUT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON UPSIZED THE POLY, REVISED THE LINER FROM A 10MM TO AN 11MM WHILE REMOVING POSTERIOR OSTEOPHYTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562080 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0510FR 2310265 07630971262003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention