BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

    MDR report key: 12126622 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00545
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    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 ON 08.JUN.2021. LOT 180921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2018. EXPIRATION DATE: 2023-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 119 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 08.JUN.2021. GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT. 180971 LOT 180971: 77 ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2018. EXPIRATION DATE: 2023-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 76 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 144885 LOT 144885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 OTHER SIMILAR REPORTED EVENT SINCE 2017 .

    Description of Event or Problem · 1

    2 YEARS AND 10 MONTHS AFTER THE LAST SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027039 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L TIBIAL INSERT FIXED SPHERE FLEX JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 180921 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention