BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY PE LINER 50/28

    MDR report key: 4782521 · Received May 15, 2015

    Report

    Report Number
    3005180920-2015-00095
    Event Type
    Injury
    Date Received
    May 15, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 03 AUGUST 2015 A FINAL REPORT WAS PREPARED WITH THE INFORMATION ALREADY REPORTED INTO THE INITIAL REPORT. ON 26 AUGUST 2015, THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015. LOT 092226: (B)(6) LINERS MANUFACTURED AND RELEASED ON (B)(6) 2009. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. ON (B)(6) 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: THERE IS NO DOCUMENTATION. WE DO NOT KNOW WHICH STEM WAS USED, IT WAS ONLY REFERRED TO US THAT A NON-MEDACTA STEM WAS COUPLED WITH THE MEDACTA VERSAFIT DOUBLE MOBILITY CUP. ALL MEDACTA STEMS HAVE A POLISHED NECK TO REDUCE THE EFFECT OF ABRASION AGAINST A DOUBLE MOBILITY LINER. THE GEOMETRY OF MEDACTA DOUBLE MOBILITY LINERS HAS BEEN DESIGNED TO MATCH NECK ANGLES AND SO LIMIT POINT-CONTACT SITUATIONS. USING A NON-MEDACTA PRODUCT THESE FEATURES ARE LOST AND THE CONSEQUENCES ARE UNK. IT IS IN FACT POSSIBLE THAT EXCESSIVE WEAR WAS GENERATED AS A CONSEQUENCE OF THIS CHOICE, BUT WE DO NOT HAVE THE ELEMENTS TO STATE SO.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318183 DOUBLE MOBILITY PE LINER 50/28 PE LINER MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1