BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION TIBIAL TRAY SIZE 1 LEFT - FINISHING

    MDR report key: 19173862 · Received April 24, 2024

    Report

    Report Number
    3005180920-2024-00263
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819322
    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 04 APRIL 2024: LOT 2104706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2021. EXPIRATION DATE: 2027-06-26. 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. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 04 APRIL 2024 ON GMK-REVISION 02.07.2402L FEMUR REVISION PS CEMENTED S.2L (K102437) LOT. 2011912. LOT 2011912: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2021. EXPIRATION DATE: 2026-02-01. 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. BATCH REVIEW PERFORMED ON 04 APRIL 2024 ON GMK-REVISION 02.07.0114SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.1 / 14 MM (K103170) LOT. 175589. LOT 175589: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-DEC-2017. EXPIRATION DATE: 2022-12-10. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. AT 2 YEARS FROM PRIMARY, THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947512 GMK-REVISION TIBIAL TRAY SIZE 1 LEFT - FINISHING KNEE REVISION TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2104706 07630030819322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention