BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L

    MDR report key: 12015486 · Received June 17, 2021

    Report

    Report Number
    3005180920-2021-00499
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825873
    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 27 MAY 2021: LOT 1901829: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2019. EXPIRATION DATE: 2024-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 1903537. BATCH REVIEW PERFORMED ON 27 MAY 2021: LOT 1903537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2019. EXPIRATION DATE: 2024-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0511FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L (K140826) LOT. 183025. BATCH REVIEW PERFORMED ON 27 MAY 2021. LOT 183025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JULY-2018. EXPIRATION DATE: 2023-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING STIFFNESS DURING FLEXION. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY 1 YEAR 6 MONTHS AFTER THE PRIMARY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914862 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0006L 1901829 07630030825873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention