BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS

    MDR report key: 17930201 · Received October 13, 2023

    Report

    Report Number
    3005180920-2023-00794
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 13, 2023
    Report Date
    October 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262003
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-OCT-2023 LOT 2242250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 2027-11-23. 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 THE REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 2219047: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 2027-11-09. 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 THE REVIEW. GMK-SPHERE 02.12.0007R FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R (K121416) LOT 2207347: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2022. EXPIRATION DATE: 2027-06-16. 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 THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS AFTER PRIMARY, 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
    1717380 GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2242250 07630971262003

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention