BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 12126590 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00571
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 16, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JUNE 2021: LOT 2005237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-AUG-2020. EXPIRATION DATE: 2025-07-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28 JUNE 2021: GMK-SPHERE 02.12.0024R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R (K140826) LOT 1906054: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2019. EXPIRATION DATE: 2024-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    4 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DURING FLEXION AND EXTENSION AND THE CAUSE IS UNKNOWN. 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
    1026684 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 2005237 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention