BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 R

    MDR report key: 19892476 · Received August 2, 2024

    Report

    Report Number
    3005180920-2024-00598
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JULY 2004 LOT 2242153: 12 ITEMS MANUFACTURED AND RELEASED ON 31-MARCH-2023. EXPIRATION DATE: 2028-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT REVISED. BATCH REVIEW PERFORMED ON 30 JULY 2024 ON GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R (K102437) LOT. 2300153. LOT 2300153: 12 ITEMS MANUFACTURED AND RELEASED ON 31-MARCH-2023. EXPIRATION DATE: 2028-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON JULY 2017. ON (B)(6) 2024, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND SHOWED TIBIAL AND FEMORAL COMPONENTS LOOSENING. NO CEMENT FOUND ON THE IMPLANT DURING THE REVISION. THE PATIENT WAS INSTABLE AND THERE WAS DEVICES MALALINGNMENT. GMK REVISION SYSTEM IMPLANTED SUCCESSFULLY. PRESENTLY ON 9 JULY 2024, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LOOSE COMPONENTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ALL THE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884532 GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 R KNEE CEMENTED FIXED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2242153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention