BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    MDR report key: 14191911 · Received April 25, 2022

    Report

    Report Number
    3005180920-2022-00297
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 5 APRIL 2022: LOT 2001731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2020. EXPIRATION DATE: 2025-FEB-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A THICKER ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171570 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 2001731 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention