BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 15247648 · Received August 18, 2022

    Report

    Report Number
    3005180920-2022-00615
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 19, 2022
    Report Date
    August 18, 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 18 AUGUST 2022. LOT 2110068: 12 ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2021. EXPIRATION DATE: 2026-NOV-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER COMPONENT INVOLVED: GMK-SPHERE 02.12.0211FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L (K140826) LOT. 171040: 30 ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2017. EXPIRATION DATE: 2022-MAY-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 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 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2737319 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0022L 2110068 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention