BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK

    MDR report key: 25039770 · Received April 30, 2026

    Report

    Report Number
    3005180920-2026-00358
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260993
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 09 APRIL 2026: GMK-SPHERIKA 02.12.E003RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S3 (K202022) LOT 2513565: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2025. EXPIRATION DATE: 2030-JUN-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.E0210FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM (K202022) LOT 2518416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2025. EXPIRATION DATE: 2030-SET-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA03R GMK SPHERIKA FEMORAL COMPONENT S3R CEMENTED (K211004) LOT 2520845: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2025. EXPIRATION DATE: 2030-OCT-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: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

    THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA AND FEMORAL COMPONENT TO A SAME SIZE PATELLA AND FEMORAL COMPONENT. THE SURGEON REVISED THE 10MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103250 GMK GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S3 JWH MEDACTA INTERNATIONAL SA 02.12.E003RP 2513565 07630971260993

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention