BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00891

    MDR report key: 8064121 · Received November 13, 2018

    Report

    Report Number
    3005180920-2018-00891
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 13, 2018
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018, LOT 122047: 59 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012 . EXPIRATION DATE: (B)(6) 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 56 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 PAIN 5 YEARS AND HALF AFTER THE PRIMARY SURGERY. THE CUP HAD ANTERIOR OVERHANG. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE CUP AND LINER WERE REVISED WITH ANOTHER COMPANY'S PRODUCT. THE HEAD WAS REVISED WITH ANOTHER MEDACTA HEAD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention