BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22902792 · Received August 27, 2025

    Report

    Report Number
    3005180920-2025-00818
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261280
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 AUGUST 2025: GMK-SPHERE 02.12.E0210FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM (K202022) LOT 2405540: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2024. EXPIRATION DATE: 25-FEB-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. MOTO PARTIAL KNEE 02.15.E029 MOTO PATELLA E-CROSS Ø29 (K213071) LOT 2344514: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024. EXPIRATION DATE: 16-JAN-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. THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. PATELLAR IMPLANT WAS ALSO REVISED DUE TO GENERIC PAIN AND INSTABILITY. 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 A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A PATELLA TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON PREFORMED A POLY TENDON REPAIR AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PATELLA PAIN AND INSTABILITY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA PATELLA WITH A COMPETITOR PATELLA AND UPSIZED THE POLY (FROM 10 TO 12 MM) TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250578 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0210FR 2405540 07630971261280

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention