BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 6 R

    MDR report key: 18316676 · Received December 13, 2023

    Report

    Report Number
    3005180920-2023-00990
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825507
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 NOVEMBER 2023: LOT 189376: (B)(4) ON (B)(6) 2019. EXPIRATION DATE: 2024-01-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: GMK-HINGE 02.09.0517UCH UC FIXED TIBIAL INSERT SIZE 5/17MM LOT. 183650: (B)(4) ON 21-AUG-2018. EXPIRATION DATE: 2023-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.09.4005R FIXED TIBIAL TRAY SIZE 5 R LOT. 187559: (B)(4) MANUFACTURED AND RELEASED ON 27-NOV-2018. EXPIRATION DATE: 2023-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.09.TA405 TIBIAL AUGMENTATION SIZE 4/5MM LOT. 171459: (B)(4) MANUFACTURED AND RELEASED ON 09-JUN-2017. EXPIRATION DATE: 2022-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.09.TA405 TIBIAL AUGMENTATION SIZE 4/5MM LOT. 173056: (B)(4) MANUFACTURED AND RELEASED ON 06-OCT-2017. EXPIRATION DATE: 2022-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.05.06DW FEMORAL WEDGE DISTAL SIZE 6/8MM LOT. 189632: (B)(4) MANUFACTURED AND RELEASED ON 08-APR-2019. EXPIRATION DATE: 2024-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.05.06PW FEMORAL WEDGE POSTERIOR SIZE 6/5MM LOT. 142961A: (B)(4) MANUFACTURED AND RELEASED ON 18-SEP-2019. EXPIRATION DATE: 2024-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.07.CS20 CONO TIBIALE 3DMETAL CENTRATO S H20 LOT. 172466: (B)(4)MANUFACTURED AND RELEASED ON 30-APR-2018. EXPIRATION DATE: 2023-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.07.FSC13065 EXTENSION STEM - CEMENTED Ø 13 L 65 LOT. 2000801: (B)(4)MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 2025-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-HINGE 02.07.FSC16065 EXTENSION STEM - CEMENTED Ø 16 L 65 LOT. 2004759: (B)(4) MANUFACTURED AND RELEASED ON 01-OCT-2020. EXPIRATION DATE: 2025-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REASON: K NUMBER OF THE OTHER COMPONENTS WERE NOT ENTERED IN THE INITIAL REPORT. GMK-HINGE 02.09.0517UCH UC FIXED TIBIAL INSERT SIZE 5/17MM - K172347. GMK-HINGE 02.09.4005R FIXED TIBIAL TRAY SIZE 5 R - K130299. GMK-HINGE 02.09.TA405 TIBIAL AUGMENTATION SIZE 4/5MM - K130299. GMK-HINGE 02.09.TA405 TIBIAL AUGMENTATION SIZE 4/5MM - K130299. GMK-HINGE 02.05.06DW FEMORAL WEDGE DISTAL SIZE 6/8MM - K102437. GMK-HINGE 02.05.06PW FEMORAL WEDGE POSTERIOR SIZE 6/5MM - K102437 . GMK-HINGE 02.07.CS20 CONO TIBIALE 3DMETAL CENTRATO S H20 - K170149. GMK-HINGE 02.07.FSC13065 EXTENSION STEM - CEMENTED Ø 13 L 65 - K120790. GMK-HINGE 02.07.FSC16065 EXTENSION STEM - CEMENTED Ø 16 L 65 - K120790.

    Description of Event or Problem · 0

    REVISION SURGERY FOR KNEE INFECTION AT 2 YEARS AND 10 MONTHS FROM PRIMARY FOR KNEE INFECTION. ALL DEVICES WERE REVISED SUCCESSFULLY AND AN ANTIBIOTIC SPACER WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580170 GMK-HINGE FEMORAL COMPONENT SIZE 6 R KNEE REVISION FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 189376 07630030825507

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention