BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 7095264 · Received December 7, 2017

    Report

    Report Number
    3005180920-2017-00734
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 11, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    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 (B)(6) 2017. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28 LOT. 162319: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016 EXPIRATION DATE: 2021-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT . COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT. 170152: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2017. EXPIRATION DATE: 2022-05-03 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 DUE TO SIGNS OF INFECTION (CORYNEBACTERIUM). THE PATIENT WAS WASHED OUT ON (B)(6) 2017. NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875973 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 162319 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention