BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK

    MDR report key: 22664405 · Received July 30, 2025

    Report

    Report Number
    3005180920-2025-00738
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 17, 2025
    Report Date
    January 7, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260993
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FU1: ADDITIONAL INFORMATION RECEIVED. EVENT DESCRIPTION (B5) UPDATED. THE PATIENT UNDERWENT REMOVAL OF THE ANTIBIOTIC SPACERS ON (B)(6) 2025, FOLLOWED BY IMPLANTATION OF THE PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 JULY 2025: GMK-SPHERIKA 02.12.E003RP PATELLA RESURFACING # 3 E-CROSS (K202022), LOT. 2425467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2024. EXPIRATION DATE: 29- SEPT-2029. NO ANOMALIES WERE 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 REVISED DEVICES BATCH REVIEW PERFORMED ON 24 JULY 2025: GMK-SPHERIKA 02.12.E0411FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 11MM (K202022), LOT. 2428505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2024. EXPIRATION DATE: 06-NOV-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.KA04L GMK SPHERIKA FEMORAL COMPONENT S4L CEMENTED (K211004), LOT. 2432489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2025. EXPIRATION DATE: 22-JAN-2030. 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.T3I4L TIBIAL TRAY FIXED CEMENTED # T3I4 L (K121416), LOT. 2431745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 FEB-2025. EXPIRATION DATE: 06 -FEB- 2030. 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: 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 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE PATIENT UNDERWENT REMOVAL OF THE ANTIBIOTIC SPACERS ON (B)(6) 2025, FOLLOWED BY IMPLANTATION OF THE PERMANENT HARDWARE THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445504 GMK GMK-SPHERIKA PATELLA RESURFACING SIZE 3 E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E003RP 2425467 07630971260993

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention