BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R

    MDR report key: 11420960 · Received March 5, 2021

    Report

    Report Number
    3005180920-2021-00178
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862663
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19.02.2021: LOT 1910205: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-GEN-2020. EXPIRATION DATE: 2024-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 6 MONTHS AFTER THE PREVIOUS REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED DUE TO INFECTION (WASHOUT AND LINER REVISION PERFORMED). THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315942 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0511FR 1910205 07630030862663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention