BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE5/10 MM R

    MDR report key: 7185278 · Received January 12, 2018

    Report

    Report Number
    3005180920-2017-00831
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    December 13, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JANUARY 2018. LOT 163076: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2016. EXPIRATION DATE: 2021-07-25. 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. VISUAL INSPECTION PERFORMED ON 09 JANUARY 2018 BY (B)(4) JOINT DIRECTOR: ON THE LATERAL SIDE OF THE ARTICULAR SURFACE (LOW CONGRUENCY ZONE), I CAN EASILY RECOGNISE THE MILLING MANUFACTURING PATTERN ON THE PE SURFACE. THIS IS A CLEAR SIGN THAT THERE ARE NO PE WEAR ON THIS SIDE. ON THE MEDIAL SIDE OF THE ARTICULAR SURFACE (HIGH CONGRUENCY ZONE), I CAN SEE A ZONE WHERE I CAN EASILY RECOGNISE THE MILLING PATTERN ON THE PE SURFACE AND A ZONE THAT HAS BEEN POLISHED BY THE CONTACT WITH THE FEMORAL COMPONENT. THE POLISHED ZONE HAS NO SIGN OF DELAMINATION AND NO EVIDENT SIGN OF WEAR. THE SPHERICAL SHAPE OF THE MEDIAL SIDE APPEARS TO BE UNALTERATED. THE INTEGRITY OF THE ENTIRE LINER IS WELL DEFINED. SOME ZONES OF THE LINER ARE YELLOWED. THIS COLOR CHANGE REPRESENTS A LIPID ABSORPTION BY THE LINER. METROLOGICAL ANALYSIS PERFORMED BY QUALITY CONTROL MANAGER 11 JANUARY 2018: BASED ON THE LOT DOCUMENTATION, NO ANOMALY WAS FOUND. THE WHOLE DOSSIER OF THE MANUFACTURER IS CONFORMING TO THE PROJECT SPECIFICATIONS. DIMENSIONAL CONTROL, HAS NOT IDENTIFIED ANY ANOMALY OR DEFECT. THE DEVICE IS CONFORMING.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PATELLA PAIN. THE SURGEON REVISED THE POLY AND RESURFACED THE PATELLA. THE SURGEON NOTICED THAT THE EXPLANTED INSERT HAD OXIDIZED (LITTLE BIT YELLOW). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28704 TIBIAL INSERT FIXED SPHERE FLEX SIZE5/10 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 163076 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention