BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 1+ L

    MDR report key: 11877173 · Received May 25, 2021

    Report

    Report Number
    3005180920-2021-00415
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862519
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MAY 2021: LOT 171803: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2017. EXPIRATION DATE: 2022-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 07 MAY 2021: GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L (K121416), LOT 2000384: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING KNEE PAIN AND STIFFNESS. THE CAUSE OF THE KNEE PAIN AND STIFFNESS IS UNKNOWN. 5 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT AND ADDED AN EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774947 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 1+ L FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0021L 171803 07630030862519

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention