BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 20852293 · Received December 5, 2024

    Report

    Report Number
    3005180920-2024-01045
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 22, 2024
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821431
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 NOVEMBER 2024. LOT 2212787: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2022. EXPIRATION DATE: 2027-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT; BATCH REVIEW PERFORMED ON 25 NOVEMBER 2024. GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 10 MM (K103170) LOT. 2311008 LOT 2311008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2023. EXPIRATION DATE: 2028-05-24. 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-REVISION 02.07.0683R REVISION TIBIAL TRAY SIZE 3 RIGHT (K123721) LOT. 2347604 LOT 2347604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2024. EXPIRATION DATE: 2029-09-12. 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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B5, TO INCLUDE THE EXPLANTATION OF THE SPACER AND IMPLANTATION OF PERMANENT PRODUCTS.

    Description of Event or Problem · 0

    REVISION DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AFTER A PRECEDENT REVISION FOR INFECTION THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR, THE TIBIAL INSERT AND THE TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT COMES FROM A PRECEDENT REVISION SURGERY FOR INFECTION (CASE CODE (B)(4), EMDR (B)(4)).

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REVISED ALL REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR (B)(4)). SUBSEQUENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK REVISION FEMUR, PS TIBIAL INSERT, AND GMK REVISION TIBA AND INSERTED A SPACES ALONG WITH PRIMARY FEMUR AND INSERT TO HOLD THE JOINT TEMPORARLY. (CURRENT MDR (B)(4)). ON THE (B)(6) 2025 THE SURGEON EXPLANDED THE SPACER AND TEMPORARY COMPONENTS AND IMPLANTED GMK HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108923 GMK REVISION TOTAL KNEE SYSTEM FEMUR REVISION PS CEMENTED S.4R JWH MEDACTA INTERNATIONAL SA 02.07.2404R 2212787 07630030821431

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention