BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R LOT. 2003109

    MDR report key: 17697145 · Received September 7, 2023

    Report

    Report Number
    3005180920-2023-00674
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821455
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2003109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2020. EXPIRATION DATE: 2025-06-21. 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. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2023. GMK-REVISION 02.07.0410SCF FIXED TIBIAL INSERT SC SIZE 4/10MM (K103170) LOT 2000822: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2020. EXPIRATION DATE: 2025-02-19. 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. GMK-REVISION 02.07.0684R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R (K123721) LOT 2003091: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2020. EXPIRATION DATE: 2025-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.FCL15065 EXTENSION STEM - FLUTED Ø 15 L 65 (K120790) LOT 2208518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2022. EXPIRATION DATE: 2027-07-12. 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. GMK-REVISION 02.07.FCL18105 EXTENSION STEM - FLUTED Ø 18 L 105 (K120790) LOT 2109488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-27. 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 A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY WAS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 14 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 17 MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE SURGEON REMOVED THE FEMUR AND INSERT THAT WAS IMPLANTED TO ACT AS A SPACER AND IMPLANTED A NEW FEMUR AND INSERT WITH ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE SURGEON REMOVED THE FEMUR AND INSERT THAT WAS IMPLANTED TO ACT AS A SPACER AND IMPLANTED REVISION KNEE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND IMPLANTED A FEMORAL COMPONENT AND FULL-PE TIBIAL COMPONENT TO ACT AS A SPACER, ALONG WITH ANTIBIOTICS, DUE TO INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926312 GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R LOT. 2003109 KNEE FEMUR REVISION JWH MEDACTA INTERNATIONAL SA 2003109 07630030821455

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention