BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R

    MDR report key: 7854956 · Received September 7, 2018

    Report

    Report Number
    3005180920-2018-00662
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826221
    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 04 SEPTEMBER 2018; LOT 162626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2016. EXPIRATION DATE: 2021-07-10; 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. CLINICAL EVALUATION PERFORMED ON 24 AUGUST 2018 BY MEDICAL AFFAIRS MANAGER 14 MONTHS AFTER PRIMARY TKR THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED. NO CONSEQUENCE SHOULD BE EXPECTED FOR THE ABSENCE OF THE SCREW IN THE FUTURE LIFE OF THE IMPLANT. THE CAUSE FOR SELF-UNSCREWING OF THE INSERT SCREW IS NOT KNOWN: ONE POSSIBILITY IS INSUFFICIENT TIGHTENING TORQUE, BUT OTHER UNKNOWN CONDITIONS MAY ALSO PLAY A ROLE.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR INLAY FIXATION SCREW UNSCREWING. INSERT REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695799 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 162626 07630030826221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention