BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER Ø 60/28

    MDR report key: 5906617 · Received August 26, 2016

    Report

    Report Number
    3005180920-2016-00433
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    July 27, 2016
    Report Date
    August 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 26 AUGUST 2016. LOT 152696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2015. EXPIRATION DATE: 2020-06-30. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE 01.29.201, LOT. 157246 (K112115). THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2016. EXPIRATION DATE: 2021-02-10. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON CONFIRMED AN INFECTION WAS PRESENT. THE PATHOGEN RESULT WILL NOT BECOME AVAILABLE. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557542 DOUBLE MOBILITY HC LINER Ø 60/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 152696

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention