BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28

    MDR report key: 6829710 · Received August 30, 2017

    Report

    Report Number
    3005180920-2017-00480
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 30, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807442
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 28 AUGUST 2017. LOT 133478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 AUGUST 2013. EXPIRATION DATE: 2018-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT. COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE 01.25.011, LOT. 130909 (K072857) LOT 130909: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE THIRD SIMILAR EVENT REPORTED ON THIS LOT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS CONFIRMED AS STAPHYLOCCOCUS. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610355 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 133478 07630030807442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention