BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMD

    MDR report key: 6141272 · Received December 2, 2016

    Report

    Report Number
    3005180920-2016-00631
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    January 4, 2017
    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

    ON 12 DECEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED EXPLANTS AND COMMENTED AS FOLLOWS: THE PIECES WERE ANALYZED. THE CERAMIC HEAD WAS INSIDE THE DM LINER. SOME SIGNS INSIDE THE HEAD WERE NOTICED, PROBABLY DUE TO THE GRIP WITH THE TAPER. A LITTLE SIGN WAS PRESENT ON THE RIM OF THE HEAD, PROBABLY OCCURRED DURING THE EXTRACTION. FROM THE RECEIVED PIECES IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON (B)(6) 2016. LOT 160828: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-05-10. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5, CODE 01.29.203, LOT. 161742 ((B)(4)). A (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-04-27. 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. NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED AN I & D AND SWAPPED THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793233 DOUBLE MOBILITY HC LINER 28/DMD DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 161392

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention