BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 8155027 · Received December 12, 2018

    Report

    Report Number
    3005180920-2018-00995
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    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 10 DECEMBER 2018. LOT 183113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JULY 2018. EXPIRATION DATE: 2023-07-04. 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 HAD A PRIMARY SURGERY ON (B)(6) 2012. ON (B)(6) 2018 A REVISION WAS PERFORMED DUE TO THE STEM SUBSIDING AND COMPLAINT 1577-18 (MDR 2018-00928) WAS FILED. THE SURGEON REVISED THE LINER WITH A MEDACTA LINER AND REVISED THE HEAD AND STEM WITH ANOTHER COMPANY'S PRODUCT. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA LINER AND THE OTHER COMPANY HEAD SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996921 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 DOUBLE MOBILITY HIP HC LINER MEH MEDACTA INTERNATIONAL SA 183113 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention