BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R E-CROSS

    MDR report key: 17640799 · Received August 29, 2023

    Report

    Report Number
    3005180920-2023-00669
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262164
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 AUGUST 2023. LOT 2211627: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2022. EXPIRATION DATE: 2027-JUL-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THIS ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 10 AUGUST 2023: GMK-SPHERE 02.15.E032 MOTO E-CROSS PATELLA D32 (K213071) LOT 2110549: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. EXPIRATION DATE: 2026-DEC-14. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A PATELLA TENDON REPAIR AND REVISED THE INSERT (WITH ONE OF THE SAME THICKNESS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101940 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R E-CROSS TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2211627 07630971262164

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention