BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 6141290 · Received December 2, 2016

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    Report

    Report Number
    3005180920-2016-00636
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 2, 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 16 NOVEMBER 2016 AND INCLUDES: THE PATIENT TESTED POSITIVE FOR (B)(6). BATCH REVIEWS PERFORMED ON 25 NOVEMBER 2016. LOT 153655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2015. EXPIRATION DATE: 2020-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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. 160545 (K112115). THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2016. EXPIRATION DATE: 2021-04-14. 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 COMPLAINING OF PAIN ON HER INCISION. SIGNS OF INFECTION. THE SURGEON PERFORMED AN I & D AND SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT TESTED POSITIVE FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791216 DOUBLE MOBILITY HC LINER 28/DMF DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 153655

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention