BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM

    MDR report key: 17325436 · Received July 14, 2023

    Report

    Report Number
    3005180920-2023-00536
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817564
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-JUN-2023. LOT 171527: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2017. EXPIRATION DATE: 2022-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 28-JUN-2023. GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R (K102437) LOT. 163514: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2016. EXPIRATION DATE: 2021-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0683R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 R (K123721) LOT. 160309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2016. EXPIRATION DATE: 2021-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. GMK-REVISION 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 148622: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS AND 3 MONTHS AFTER THE PREVIOUS REVISION SURGERY DUE TO INSTABILITY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK HINGE. THE PATIENT HAD ALREADY UNDERWENT TO DIFFERENT SURGERIES DUE TO MULTIPLE INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180556 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM KNEE TIVIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0326SCF 171527 07630030817564

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention