BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 11036667 · Received December 18, 2020

    Report

    Report Number
    3005180920-2020-00932
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2020: LOT 1910707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-FEB-2020. EXPIRATION DATE: 2025-01-21. 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, 2 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A QUAD TENDON RUPTURE. THE CAUSE OF THE QUAD TENDON RUPTURE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S3R - 12MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3R - 12MN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507066 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 1910707 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention