BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25040713 · Received April 30, 2026

    Report

    Report Number
    3005180920-2026-00367
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261679
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 APRIL 2026: GMK-SPHERIKA 02.12.E0314FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 14MM (K202022), LOT: 2338079: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2023. EXPIRATION DATE: 2028-SEP-18. 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.KA13L GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED (K211004) LOT: 2408287: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2024. EXPIRATION DATE: 2029-JUN-11. 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: THE REVISION PROCEDURE, INCLUDING INCREASE OF LINER THICKNESS, FEMORAL COMPONENT REVISION, AND EXTENSION STEM EXCHANGE TO A LONGER FLUTED STEM, WAS UNDERTAKEN TO ADDRESS JOINT INSTABILITY. BASED ON THE AVAILABLE INFORMATION, NO DEVICE-RELATED ISSUES HAVE BEEN IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN PRESENTING INSTABILITY, THE REASON IS UNKNOWN. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE 14MM INSERT TO A 17MM INSERT, REVISED THE GMK-SPHERIKA S3 FEMORAL COMPONENT TO A GMK-REVISION S4 FEMORAL COMPONENT, AND REVISED THE PRIMAY L30MM EXTENSION STEM WITH A FLUTED L150MM EXTENSION STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107053 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 14MM JWH MEDACTA INTERNATIONAL SA 02.12.E0314FL 2338079 07630971261679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention