BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R

    MDR report key: 18281396 · Received December 7, 2023

    Report

    Report Number
    3005180920-2023-00987
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040720243
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-NOV-2023 LOT 111212: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2011. EXPIRATION DATE: 2016-06-30. 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. ADDITIONAL ITEMS INVOLVED IN THE COMPLAINTS, BATCH REVIEW PERFORMED ON 20 NOVEMBER 2023: GMK-PRIMARY 02.07.0217SF TIBIAL INSERT STD FIXED SIZE 2 / 17 MM (K090988) LOT. 101410 LOT 101410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2010. EXPIRATION DATE: 2015-04-30. 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-PRIMARY 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT. 112613 LOT 112613: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2011. EXPIRATION DATE: 2016-09-30. 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 REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 11 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE GMK PRIMARY FEMORAL COMPONENT, INSERT AND TIBIAL TRAY AND CONVERTED THE PATIENT TO A HINGE KNEE AND THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086028 GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 111212 07630040720243

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention