BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 2 R

    MDR report key: 10821834 · Received November 11, 2020

    Report

    Report Number
    3005180920-2020-00790
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821394
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 OCTOBER 2020 LOT 189488: 24 ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED:GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT. 1903716 BATCH REVIEW PERFORMED ON 20 OCTOBER 2020 LOT 1903716: 11 ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.0220SCF FIXED TIBIAL INSERT SC SIZE 2/20MM (K103170) LOT. 178510 BATCH REVIEW PERFORMED ON 20 OCTOBER 2020 LOT 178510: 18 ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2018. EXPIRATION DATE: 2023-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.FCL15105 EXTENSION STEM - FLUTED Ø 15 L 105 (K120790) LOT. 1900650 BATCH REVIEW PERFORMED ON 20 OCTOBER 2020 LOT 1900650: 45 ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2019. EXPIRATION DATE: 2024-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.FCL14105 EXTENSION STEM - FLUTED Ø 14 L 105 (K120790) LOT. 167136A BATCH REVIEW PERFORMED ON 20 OCTOBER 2020 LOT 167136A: 1 ITEM MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, 5 MONTHS AFTER PRIMARY SURGERY, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A MEDACTA FEMUR AND POLY WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286239 GMK-REVISION FEMUR REVISION PS SIZE 2 R CEMENTED FEMUR COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2402R 189488 07630030821394

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention