BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 52/28

    MDR report key: 6547273 · Received May 5, 2017

    Report

    Report Number
    3005180920-2017-00237
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    April 7, 2017
    Report Date
    November 17, 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

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: THE SURGEON WASHED OUT THE PATIENT AND REVISED THE HEAD AND LINER. THE PATHOGEN IS CONFIRMED AS E. COLI. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017. ON 28 APRIL 2017 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: EARLY INFECTION IN THA, 1 MONTH 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 02 MAY 2017. LOT 162321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016. EXPIRATION DATE: 2021-06-29. 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 M 0, CODE 01.29.202, LOT. 164974 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2016. EXPIRATION DATE: 2021-10-25. 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. ON 04 MAY 2017 THE (B)(4) PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE PICTURE AND COMMENTED AS FOLLOWS: THE IMAGE WAS CHECKED, SHOWING THE DM LINER AND HEAD ASSEMBLED TOGETHER AFTER THE REMOVAL FROM THE PATIENT, BOTH COVERED WITH BLOOD AND WITH SOME SIGNS OF REMOVAL ON THE RIM OF THE CERAMIC HEAD. FROM THE RECEIVED IMAGE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS CONFIRMED AS E. COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330718 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 52/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 162321

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention