BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM LINE 28/52

    MDR report key: 4782509 · Received May 15, 2015

    Report

    Report Number
    3005180920-2015-00090
    Event Type
    Injury
    Date Received
    May 15, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 6, 2015, IT WAS PREPARED A FINAL REPORT WITH THE INFO COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 MAY 2015. LOT 140857: (B)(4) LINERS MANUFACTURED AND RELEASED ON 06 JUNE 2014. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. ON 23 APRIL 2015 WE HAVE BEEN INFORMED THAT THE EXPLANTED ITEMS WILL NOT RETURN AND NO INFORMATION WAS AVAILABLE ON THE PATHOGEN. ON 01 MAY 2015 THE (B)(4) MADE THE FOLLOWING COMMENT: THIS CASE HAS BEEN REPORTED AS AN INFECTION. THE DEVICES LOOKED IMPLANTED CORRECTLY. WE HAVE NO REASONS TO DOUBT THAT THE ROOT CAUSE IS IN FACT INFECTION, A KNOWN POSSIBLE COMPLICATION OF TOTAL JOINT REPLACEMENTS. ON 04 MAY 2015 THE CERAMIC MANUFACTURER CONFIRMED US THAT THE DHR OF THE LOT OF THE CERAMIC HEAD INVOLVED WAS OK.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318060 VERSAFITCUP DM LINE 28/52 ACETABULAR DM PE LINER MEH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1