BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8775239 · Received July 10, 2019

    Report

    Report Number
    3005180920-2019-00557
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JUN 2019: LOT 1810394: 100 ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 03-03-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 3 WEEKS AFTER PRIMARY SURGERY, FOR A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571991 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1810394 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention