BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMH

    MDR report key: 9289628 · Received November 7, 2019

    Report

    Report Number
    3005180920-2019-00944
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 7, 2019
    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 22 OCTOBER 2019. LOT 1811183: 129 ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2019. EXPIRATION DATE: 2024-01-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 84 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED IN THE EVENT. BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857). BATCH REVIEW PERFORMED ON 22 OCTOBER 2019. LOT 1810701: 120 ITEMS MANUFACTURED AND RELEASED ON 23-APR-2019. EXPIRATION DATE: 2024-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 93 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, COMPLAINING OF PAIN DUE TO LACK OF HEALING ON THE WOUND SITE. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA 28MM COCR HEAD M WITH A MEDACTA 28MM COCR HEAD M AND THE MEDACTA VERSAFITCUP DM LINER HC 56/28 WITH A MEDACTA VERSAFITCUP DM LINER HC 56/28 DUE TO SUSPECT OF INFECTION. NO DEEP INFECTION CONFIRMED DURING AND AFTER SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088021 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMH DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 1811183 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention