BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 6138414 · Received December 1, 2016

    Report

    Report Number
    3005180920-2016-00624
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    October 31, 2016
    Report Date
    February 1, 2017
    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

    ON 30 JANUARY 2017, THE MEDICAL AFFAIRS DIRECTOR UPDATED THE CLINICAL EVALUATION REPORTED IN THE INITIAL REPORT ON THE BASIS OF ALL AVAILABLE INFORMATION AS FOLLOWS: TWO WEEKS AFTER PRIMARY CEMENTLESS THA, REOPERATION WAS REQUIRED BECAUSE OF A PERSISTENT HAEMATOMA. THIS IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Additional Manufacturer Narrative · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE HIP AND SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 11 NOVEMBER 2016 AND INCLUDES: THE PATHOGEN ANALYSIS FOUND NO ORGANISM, THE FINAL CULTURES WERE NEGATIVE. THE DISCHARGE DIAGNOSIS WAS HEMATOMA. ON 24 NOVEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: EARLY INFECTION IN CEMENTLESS THA, TWO WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 25 NOVEMBER 2016. LOT 150126: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE 01.29.201, LOT. 161740 (K112115). THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MAY 2016. EXPIRATION DATE: 2021-05-16. 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

    REVISION PERFORMED DUE TO SIGNS OF INFECTION. THE PATHOGEN ANALYSIS FOUND NO ORGANISM, THE FINAL CULTURES WERE NEGATIVE. THE DISCHARGE DIAGNOSIS WAS HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789784 DOUBLE MOBILITY HC LINER 28/DMF DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 150126

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention