BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DME

    MDR report key: 6126996 · Received November 24, 2016

    Report

    Report Number
    3005180920-2016-00609
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 07 NOVEMBER 2016 AND INCLUDES: THE PATHOGEN IS STAPHYLOCOCCUS ELI. BATCH REVIEWS PERFORMED ON 21 NOVEMBER 2016. LOT 157122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 FEBRUARY 2016. EXPIRATION DATE: 2021-02-09. 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. COCR BALL HEAD 12/14 Ø 28 SIZE XL +7, CODE 01.25.014, LOT. 152717 (K072857) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 AUGUST 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE HIP AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777862 DOUBLE MOBILITY HC LINER 28/DME DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 157122

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention