BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    MDR report key: 12545489 · Received September 29, 2021

    Report

    Report Number
    3005180920-2021-00780
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 29, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    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 01 SEPTEMBER 2021. LOT 140327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2014. EXPIRATION DATE: 2019-01-31. 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 PAIN AND THE SURGEON TOOK X-RAYS THAT REVEALED THAT THE SCREW FROM THE TIBIAL INSERT HAD BACKED OUT. THE SURGEON REMOVED THE BACKED-OUT SCREW AND REVISED THE POLY AND TIBIA 4 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445003 TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L KNEE FIXED INLAY JWH MEDACTA INTERNATIONAL SA 02.12.0414FL 140327 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention