BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28

    MDR report key: 11037519 · Received December 18, 2020

    Report

    Report Number
    3005180920-2020-00956
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 18, 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 11 DECEMBER 2020 LOT 2001457: 110 ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2020. EXPIRATION DATE: 2025-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 61 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT. 2001935 BATCH REVIEW PERFORMED ON 11 DECEMBER 2020 LOT 2001935: 120 ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2020. EXPIRATION DATE: 2025-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 49 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506168 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 2001457 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention