BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

    MDR report key: 7032801 · Received November 15, 2017

    Report

    Report Number
    3005180920-2017-00660
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807374
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 13 NOVEMBER 2017. LOT 110327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2011. EXPIRATION DATE: 2016-02-29. 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 FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0, CODE 38.39.7175.255.00, LOT. 104432 (K073337) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812260 VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 110327 07630030807374

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention