BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    MDR report key: 12133386 · Received July 8, 2021

    Report

    Report Number
    3005180920-2021-00568
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24.JUNE.2021: LOT 156273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-01-2016. EXPIRATION DATE: 2021-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,ALL ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS SINCE 2017. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L (K121416) LOT. 152006. BATCH REVIEW PERFORMED ON 24.JUNE.2021: LOT 152006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-05-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS SINCE 2017. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT. 156095. BATCH REVIEW PERFORMED ON 24.JUNE.2021: LOT 156095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-02-2015. EXPIRATION DATE: 2021-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS SINCE 2017.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ABOUT 5 YEARS AFTER THE PRIMARY SURGERY DUE TO LOW-GRADE INFECTION. ALL IMPLANTS WERE REVISED. THE EXACT PRIMARY DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030131 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004L 156273 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention