BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI

    MDR report key: 9675221 · Received February 6, 2020

    Report

    Report Number
    3005180920-2020-00023
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 6, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2020: LOT 1902877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2019. EXPIRATION DATE: 2025-06-05. 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 HIP SURGERY AND WAS IMPLANTED WITH COMPETITOR ITEMS. THE DATE OF THE PRIMARY SURGERY IS UNKNOWN. SUBSEQUENTLY ON (B)(6) 2019, THE PATIENT CAME IN DUE TO METALLOSIS IN THE HIP. THE SURGEON REVISED THE PATIENT WITH A MEDACTA LINER. PRESENTLY, ON (B)(6) 2020, ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE COMPETITOR HEAD AND MEDACTA LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138357 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2858MHC 1902877 07630030807442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention