BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DM DOUBLE MOBILITY HC LINER Ø60/28

    MDR report key: 7292097 · Received February 23, 2018

    Report

    Report Number
    3005180920-2018-00094
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 23, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2018: LOT 160849: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MAY 2016. EXPIRATION DATE: 2021-04-04. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 28 SIZE M 0 REFERENCE 01.25.012 (K072857) LOT 172861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 CAME IN DUE TO SIGNS OF HEMATOMA 10 DAYS AFTER SURGERY. THE SURGEON REVISED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136073 MPACT DM DOUBLE MOBILITY HC LINER Ø60/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 160849 07630030807473

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention