BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2019-00265

    MDR report key: 8508145 · Received April 12, 2019

    Report

    Report Number
    3005180920-2019-00265
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 12, 2019
    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 08 APRIL 2019: LOT 172818: 75 ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2017. EXPIRATION DATE: 2022-06-25. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF A CLICKING NOISE AND INSTABILITY OF THE KNEE 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE 10MM POLY WITH A 13MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD GLOBAL LAXITY IN THE KNEE AND DURING CERTAIN GAIT MOTIONS PATIENT FELT THERE WAS A SMALL CLICK DUE TO THE LAXITY. THE THICKER INSERT RESOLVED BOTH THE INSTABILITY AND CLICK.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention