BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    MDR report key: 17852274 · Received October 2, 2023

    Report

    Report Number
    3005180920-2023-00770
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 2, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2023: LOT 2010190: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2020. EXPIRATION DATE: 2025-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2023: GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L (K121416) LOT. 2010601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-10-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2023: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 2103807: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUNE-2021. EXPIRATION DATE: 2026-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR INFECTION AT 1 YEAR AND 11 MONTHS POST PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280971 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2010190 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention