BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM

    MDR report key: 17190147 · Received June 23, 2023

    Report

    Report Number
    3005180920-2023-00469
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 26, 2023
    Report Date
    June 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825682
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 JUNE 2023: LOT 1910561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2020. EXPIRATION DATE: 2025-01-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEWS PERFORMED ON 12 JUNE 2023: GMK-REVISION 02.07.10.3502 REVISION TRIAL TIBIAL SPACER SIZE 2 LOT 1412518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 12 JUNE 2023 GMK-REVISION 02.07.ES20 ECCENTRIC 3DMETAL TIBIAL CONE S H20 (K170149) LOT 186775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. INVESTIGATION ON THE PICTURES RECEIVED PERFORMED BY MEDACTA KNEE R&D PROJECT MANAGER: EVEN IF THE TRIAL TIBIAL AUGMENTS HAVE THE EXTERNAL SHAPE AND DIMENSION A LITTLE DIFFERENT THAN THE FINAL IMPLANT (DIFFERENCE JUSTIFIED BY THE NEED TO REDUCE THE NUMBER OF TRIAL DEVICE TO BE USED DURING THE SURGERY), THE SURGEON TRIED TO IMPLANT AN ECCENTRIC CONE IN COMBINATION WITH TIBIAL AUGTMENT. THIS COMBINATION IS NOT PERMITTED AS DESCRIBED INTO THE SPECIFIC TIBIAL CONES SURGICAL TECHNIQUE. THE CASE HAS TO BE CONSIDERED AN OUT OF LABEL PROCEDURE.

    Description of Event or Problem · 0

    DURING THE KNEE REVISION OF A COMPETITOR'S IMPLANTS AND WHILE TRIALING FOR THE AUGMENT, IT WAS OBSERVED THAT THE DIMENSIONAL PROFILE OF THE TRIAL AUGMENT WAS NOT THE SAME AS THE ACTUAL AUGMENT IMPLANT. THE ECCENTRIC CONE COULD BE COUPLED TO THE AUGMENT TRIAL, WHILE THE IMPLANT COULD NOT. THE SURGEON UTILIZED A METAL CUTTING WHEEL TO CUT THE ECCENTRIC CONE, IN ORDER FOR THE AUGMENT TO FIT. THERE WAS A 30-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE THAT AUGMENT SHOULD NOT BE COUPLED WITH THE CONE, THIS IS AN OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944659 GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM KNEE TIBIAL AUGMENT KRO MEDACTA INTERNATIONAL SA 02.09.TA210 1910561 07630030825682

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other