BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMM

    MDR report key: 5999710 · Received October 5, 2016

    Report

    Report Number
    3005180920-2016-00515
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 5, 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

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH NON-MEDACTA PRODUCTS. ON (B)(6) 2016 THE PATIENT CAME IN WITH AN INFECTION. THE SURGEON REVISED WITH A MEDACTA CUP AND LINER. ADDITIONAL INFORMATION RECEIVED ON 19 SEPTEMBER 2016 AND INCLUDES: THE PATHOGEN IS STAPH. COAG. POSITIVE. BATCH REVIEW PERFORMED ON 03 OCTOBER 2016. LOT 150132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 APRIL 2015. EXPIRATION DATE: 2020-02-29. 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 PRESENTED WITH SIGNS OF INFECTION. THE SURGEON REVISED THE HEAD (NON-MEDACTA PRODUCT) AND THE LINER (MEDACTA PRODUCT). THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652220 DOUBLE MOBILITY HC LINER 28/DMM DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 150132

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention