BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L

    MDR report key: 11884446 · Received May 26, 2021

    Report

    Report Number
    3005180920-2021-00418
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 MAY 2021: LOT 161665: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2016. EXPIRATION DATE: 2021-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 06 MAY 2021: GMK-SPHERE 02.12.0313FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L (K140826)LOT 146603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2015. EXPIRATION DATE: 2019-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017. GMK-SPHERE 02.07.1201L TIBIAL TRAY FIXED CEMENTED SIZE 1 L (K090988) LOT 153502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2015. EXPIRATION DATE: 2020-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING TIGHTNESS DUE TO THE PRESENCE OF SCAR TISSUE. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT 4 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782086 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0022L 161665 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention