BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER DIAM 52/28

    MDR report key: 6221201 · Received January 4, 2017

    Report

    Report Number
    3005180920-2016-00700
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 6, 2016
    Report Date
    April 28, 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

    ADDITIONAL INFORMATION RECEIVED ON 08 DECEMBER 2016 AND INCLUDES: THIS IS NOT A PACKAGING ERROR, THIS WAS A MISTAKE BY THE HOSPITAL STAFF. BATCH REVIEWS PERFORMED ON 22 DECEMBER 2016. LOT. 160845: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MAY 2016. EXPIRATION DATE: 2021-05-01. 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. 163444 (K112115). LOT 163444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-05. 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. AS CONFIRMED BY THE MEDICAL AFFAIRS DIRECTOR ON 23 DECEMBER 2016, NO CLINICAL INVESTIGATION IS REQUIRED BECAUSE THIS PROBLEM WAS NOT GENERATED BY A DEFECT IN IMPLANT PACKAGING OR PRODUCTION, ACCORDING TO REPORT. PRELIMINARY INVESTIGATION CONDUCED BY MEDACTA ON 03 JANUARY 2016, REPORTING AS FOLLOWS: AS STATED IN THE REPORT, THE SURGEON USED A BLACK TRIAL LINER Ø58, PRESUMABLY THE OLD VERSAFITCUP DM TRIAL VERSION, IMPLANTING THEN A BLACK LINER (FINAL IMPLANT) Ø 52. THIS WAS CONFIRMED AS A MISTAKE BY THE HOSPITAL STAFF. IN THE VERSAFITCUP DM SURGICAL TECHNIQUE IS NOT REPORTED THAT THE FINAL IMPLANT LINER COLOR MATCH WITH THE COLOR OF THE TRIAL LINER. THE MEDICAL STAFF SHOULD ALWAYS REFER TO THE DIAMETER REPORTED ON THE DEVICES IN ORDER TO BE SURE THE TRIAL LINER AND THE FINAL IMPLANT HAVE THE SAME DIAMETER. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 28 APRIL 2017, THE R&D PROJECT MANAGER PERFORMED THE VISUAL INSPECTION OF THE RETRIEVED EXPLANT AND COMMENTED AS FOLLOWS: THE REVISED IMPLANT DID NOT SHOW ANY PARTICULAR SIGNS OR DAMAGES. THE DM LINER SURFACE WAS WITHOUT SIGNS OR DAMAGES AND THE CERAMIC BALL HEAD SHOWED ONLY SOME SIGNS MOST PROBABLY DUE TO THE REMOVAL PHASE. THE COLOR CODE WAS INCORRECTLY USED AND, AS COMMUNICATED TO MEDACTA, THE FAULT WAS OF THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: IT WAS CONFIRMED THAT THE EXPLANTS WILL NOT BECOME AVAILABLE.

    Description of Event or Problem · 1

    AFTER THE SURGEON COMPLETED THE PRIMARY HIP, HE NOTICED THAT HE IMPLANTED THE WRONG SIZE LINER. THE TRAIL 58 LINER (BLACK) DID NOT MATCH THE POLY LINER IMPLANT BOX. THE SURGEON IMPLANTED A 52 LINER AS THE COLOR MATCHED THE TRAIL 58 LINER (BLACK). THE SAME DAY, THE SURGEON REVISED THE HEAD AND LINER WITH THE CORRECTED SIZES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS NOT A PACKAGING ERROR, THIS WAS A MISTAKE BY THE HOSPITAL STAFF. X-RAYS ARE AVAILABLE. EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4427 DOUBLE MOBILITY HC LINER DIAM 52/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 160845

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention