BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9852031 · Received March 19, 2020

    Report

    Report Number
    3005180920-2020-00168
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    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 02 MARCH 2020: LOT 173817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEPT-2017. EXPIRATION DATE: 2022-09-10. 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 INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON, ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY SURGERY REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 10MM S5 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 14MM S5 FOR MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317233 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 173817 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention