BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 12258362 · Received August 2, 2021

    Report

    Report Number
    3005180920-2021-00664
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 2, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 28.JULY.2021: LOT 2002755: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-06-2020. EXPIRATION DATE: 2025-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K121416) LOT. 1907905. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 28.JULY.2021: LOT 1907905: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-11-2019. EXPIRATION DATE: 2024-11-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 2002936 BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 28.JULY.2021: LOT 2002936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-07-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    5 MONTHS AFTER THE LAST REVISION 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 IMPLANTED THE PATIENT WITH NEW PERMANENT HARDWARE. THIS IS THE 2ND REVISION SURGERY PERFORMED DUE TO INFECTION, PREVIOUSLY ON (B)(6) 2021, THE SURGEON REVISED THE INSERT. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160585 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 2002755 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention