BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    MDR report key: 20064726 · Received August 26, 2024

    Report

    Report Number
    3005180920-2024-00674
    Event Type
    Injury
    Date Received
    August 26, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-AUG-2024. LOT 2301711: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2023. EXPIRATION DATE: 2028-03-19. 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 AND INVOLVED: BATCH REVIEW PERFORMED ON 21-AUG-2024. GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3I4 L (K121416) LOT. 2248082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-12. 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 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2246244: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2023. EXPIRATION DATE: 2028-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS (K202022) LOT. 2242231: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN IN THE KNEE. THE PATIENT HAD A MEDACTA SPHERE KNEE IMPLANTED ON (B)(6) 2023. IT IS UNKNOWN IF A REVISION SURGERY HAS BEEN DONE OR PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232124 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2301711 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention