BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMD

    MDR report key: 5935398 · Received September 8, 2016

    Report

    Report Number
    3005180920-2016-00459
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    August 9, 2016
    Report Date
    October 7, 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 05 SEPTEMBER 2016. LOT 142656: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. 148054 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. 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.

    Additional Manufacturer Narrative · 1

    ON 09 SEPTEMBER 2016, (B)(4), THE SUPPLIER OF THE CERAMIC COMPONENT, PROVIDED A BATCH REVIEW OF THE INVOLVED LOT AND COMMENTED AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE PAIN MAY BE ACTIVITY RELATED. THE ACTIVITY WAS NOT DEFINED BY THE SURGEON. LIKELY, THE PATIENT LIVES AN ACTIVE LIFESTYLE. THE SURGEON CLEARED OUT SCAR TISSUE AND REVISED 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
    586997 DOUBLE MOBILITY HC LINER 28/DMD DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 142656

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention