BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM

    MDR report key: 19077327 · Received April 10, 2024

    Report

    Report Number
    3005180920-2024-00192
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817076
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-MAR-2024. LOT 2238093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2022. EXPIRATION DATE: 2027-11-09. 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: GMK-REVISION 02.07.0683L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L (K123721) LOT 2215011: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-27. 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. GMK-REVISION 02.07.2403L FEMUR REVISION PS SIZE 3 L (K102437) LOT 2207826: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2022. EXPIRATION DATE: 2027-07-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS PRIOR TO MEDACTA REVISION SYSTEM IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413306 GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 07630030817076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention