BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11412241 · Received March 4, 2021

    Report

    Report Number
    3005180920-2021-00161
    Event Type
    Injury
    Date Received
    March 4, 2021
    Date of Event
    February 25, 2021
    Report Date
    June 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826825
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 WE HAVE RECEIVED THE INFORMATION THAT THE REVISION SURGERY WAS CANCELLED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS INITIALLY PLANNED FOR (B)(6)2021, 11 MONTHS AFTER THE PRIMARY SURGERY. THE REASON IS INSTABILITY. THE SURGEON PLANNED TO USE A HIGHER INSERT AND TO RESURFACE PATELLA BONE. FINALLY, THE SURGERY WAS CANCELLED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12.FEB.2021: LOT 189062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-MAR-2019. EXPIRATION DATE: 2024-02-24. 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

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, 11 MONTHS AFTER THE PRIMARY SURGERY. THE REASON IS INSTABILITY. IT IS NOT CONFIRMED WHICH IMPLANTS WERE REVISED BUT THE SURGEON PLANNED BEFORE THE REVISION TO USE A HIGHER INSERT AND TO RESURFACE PATELLA BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308370 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0514FR 189062 07630030826825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention