BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28

    MDR report key: 9502120 · Received December 20, 2019

    Report

    Report Number
    3005180920-2019-01100
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807473
    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 09 DECEMBER 2019: LOT 162329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2016. EXPIRATION DATE: 2021-06-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP ALMOST 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300390 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 162329 07630030807473

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention