BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø28/B

    MDR report key: 7199212 · Received January 17, 2018

    Report

    Report Number
    3005180920-2017-00842
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 18, 2017
    Report Date
    January 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811531
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JANUARY 2018 LOT 165672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 OCTOBER 2016. EXPIRATION DATE: 2021-09-20 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 01.29.203 (K112115) LOT. 168599: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 207. EXPIRATION DATE: 2022-03-26 NO ANOMALIES FOUND RELATED TO THE PROBLEM. 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 DUE TO DISLOCATION. NO TRAUMA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45491 MPACT FLAT PE HC LINER Ø28/B FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 165672 07630030811531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention