BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 10748130 · Received October 28, 2020

    Report

    Report Number
    3005180920-2020-00747
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    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 08 OCTOBER 2020. LOT 2000168: 165 ITEMS MANUFACTURED AND RELEASED ON 07-APR-2020. EXPIRATION DATE: 2025-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 87 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 08 OCTOBER 2020. BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT. 1910796 LOT 1910796: 150 ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 2025-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 108 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213379 LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER 28/DMF DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 2000168 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention