BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21503937 · Received March 3, 2025

    Report

    Report Number
    3005180920-2025-00160
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825880
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 FEBR 2025, (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2023. EXPIRATION DATE: 2028-06-25. 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 IMPLANTS ALSO REVISED: GMK-REVISION 02.07.0685R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 R (K123721) LOT. 2304610 BATCH REVIEW PERFORMED ON 17 FEBR 2025, (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2023. EXPIRATION DATE: 2028-08-05. 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. GMK-SPHERE 02.12.E003RP PATELLA RESURFACING SIZE 3 E-CROSS (K202022) LOT. 2247076 BATCH REVIEW PERFORMED ON 17 FEBR 2025, (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2023. EXPIRATION DATE: 2028-03-13. 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. GMK-SPHERE 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT. 2307853. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2023. EXPIRATION DATE: 2028-06-06. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT 1 YEAR AND 3 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676995 GMK SPHERE TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R JWH MEDACTA INTERNATIONAL SA 02.12.0006R 2308882 07630030825880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention