BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

    MDR report key: 19328371 · Received May 16, 2024

    Report

    Report Number
    3005180920-2024-00308
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862441
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-APR-2024. LOT 2116109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2022. EXPIRATION DATE: 2027-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS REVISED: GMK-SPHERE 02.12.E0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS (K202022) LOT 2110577: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2021. EXPIRATION DATE: 2026-09-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT 2109874: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E003RP PATELLA RESURFACING SIZE 3 E-CROSS (K202022) LOT 2210652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2022. EXPIRATION DATE: 2027-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648751 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2116109 07630030862441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention