BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22904219 · Received August 27, 2025

    Report

    Report Number
    3005180920-2025-00800
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 AUGUST 2025. GMK-SPHERIKA 02.07.1202L GMK TIBIAL TRAY CEMENTED LEFT S2 (K090988). LOT. 2418280: (B)(4) ITEMS. MANUFACTURED AND RELEASED ON 25-SEPT-2024. EXPIRATION DATE: 12-SEPT-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. GMK-SPHERIKA 02.12.E002RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S2 (K202022), LOT. 2411320: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2024. EXPIRATION DATE: 10-JUNE-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. GMK-SPHERIKA 02.12.E0210FL TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L E-CROSS (K202022), LOT. 2421766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEPT-2024. EXPIRATION DATE: 25-AUG-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. GMK-SPHERIKA 02.12.KA03L GMK SPHERIKA FEMORAL COMPONENT S3L CEMENTED (K211004), LOT. 2411253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2024. EXPIRATION DATE: 22-JULY-2029. 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. CONCLUSIONS: 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 ABOUT 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498903 GMK PRIMARY TOTAL KNEE SYSTEM GMK TIBIAL TRAY CEMENTED LEFT S2 JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2418280 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention