BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER

    MDR report key: 7087191 · Received December 6, 2017

    Report

    Report Number
    3005180920-2017-00731
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807442
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 DECEMBER 2017. LOT 165712: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 NOVEMBER 2016. EXPIRATION DATE: 2021-10-26. 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 DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 REFERENCE 01.29.203 (K112115). LOT 170685: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2017. EXPIRATION DATE: 2022-05-10 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN PRESENTING WITH A HEMATOMA. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866404 VERSAFITCUP DOUBLE MOBILITY HC LINER DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 165712 07630030807442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention