BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

    MDR report key: 12983265 · Received December 13, 2021

    Report

    Report Number
    3005180920-2021-00980
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817991
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 NOVEMBER 2021: LOT 1903723: 25 ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2019. EXPIRATION DATE: 2024-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 24-NOV-2021: GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R (K102437) LOT. 174928 LOT 174928: 23 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2017. EXPIRATION DATE: 2022-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0684R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R (K123721) LOT. 1908398 LOT 1908398: 10 ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2020. EXPIRATION DATE: 2025-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR HARDWARE. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE COMPETITOR HARDWARE REVISED TO MEDACTA HARDWARE FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6), THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887518 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0417SCF 1903723 07630030817991

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention