BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DM DOUBLE MOBILITY HC LINER Ø 28/DMG

    MDR report key: 8073339 · Received November 15, 2018

    Report

    Report Number
    3005180920-2018-00903
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2018: LOT 183982: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JULY 2018. EXPIRATION DATE: 2023-06-07. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0. REFERENCE 01.29.202 (K112115). LOT 174692: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 FEBRUARY 2018. EXPIRATION DATE: 2023-01-21. 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

    REVISION SURGERY PERFORMED 3 WEEKS AFTER PRIMARY DUE TO PAIN (UNKNOWN REASON). THE SURGEON REVISED THE LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914066 MPACT DM DOUBLE MOBILITY HC LINER Ø 28/DMG DOUBLE MOBILITY LINER LZO MEDACTA INTERNATIONAL SA 183982 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention