BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 8101420 · Received November 26, 2018

    Report

    Report Number
    3005180920-2018-00940
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2018; LOT 180668: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 MAY 2018 . EXPIRATION DATE: 2023-05-13; 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. OTHER DEVICE INVOLVED COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 REFERENCE 01.25.015 (K072857); LOT 180639: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2018. EXPIRATION DATE: 2023-05-14; 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

    ABOUT 10 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR AN INFECTION CASE. LINER AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942855 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 180668 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention