BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 15408758 · Received September 13, 2022

    Report

    Report Number
    3005180920-2022-00684
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 15, 2022
    Report Date
    September 13, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON 22-AUG-2022: LOT 2101922: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT 2008493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2020. EXPIRATION DATE: 2025-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E001RP PATELLA RESURFACING SIZE 1 E-CROSS (K202022) LOT 2002542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2020. EXPIRATION DATE: 2025-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS (K202022) LOT 2012370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 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
    1969535 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0022L 2101922 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention