BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

    MDR report key: 10354785 · Received August 3, 2020

    Report

    Report Number
    3005180920-2020-00510
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826184
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 24 JULY 2020: LOT 143385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6 JUNE 2014. EXPIRATION DATE: 2019-04-30, NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A SCREW FROM THE TIBIAL INSERT HAD LOOSENED. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822224 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0212FR 143385 07630030826184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention