BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: DM DOUBLE MOBILITY HC LINER 28/DMD

    MDR report key: 4964007 · Received July 31, 2015

    Report

    Report Number
    3005180920-2015-00169
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    November 6, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 IT WAS COMMUNICATED THAT THE CAUSE OF INFECTION WAS STAPHYLOCOCCAL EPIDERMIS "DIPHTHRODOIDS". ON 09 OCT 15 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 31, 2015: LOT 150124: (B)(4) LINERS MANUFACTURED AND RELEASED ON APRIL 14, 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 148053: (B)(4) HEADS MANUFACTURED AND RELEASED ON APRIL 17, 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) HEADS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON JULY 22, 2015: IT WAS VERIFIED THAT THIS IS THE FIRST EVENT ON THE LOTS INVOLVED IN THE COMPLAINT. NO OTHER EVENTS ARE REGISTERED ON THE SAME STERILIZATION LOTS OF THE PIECES INVOLVED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498852 LINER: DM DOUBLE MOBILITY HC LINER 28/DMD DM LINER HC MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1