BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R

    MDR report key: 11946022 · Received June 7, 2021

    Report

    Report Number
    3005180920-2021-00477
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862441
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MAY 2021: LOT 183465: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 14 MAY 2021: GMK-SPHERE 02.12.0610FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R (K121416) LOT 183072: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING DISCOMFORT AND TIGHTNESS IN THE KNEE AND THE CAUSE OF THE DISCOMFORT AND TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND ADDED AN EXTENSION STEM AND OFFSET CONNECTOR 2 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844147 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0026R 183465 07630030862441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention