BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 7013791 · Received November 9, 2017

    Report

    Report Number
    3005180920-2017-00640
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 170979: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2017. EXPIRATION DATE: 2022-05-14.. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0, CODE 01.29.209, LOT. 171413 (K112115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2017. EXPIRATION DATE: 2022-07-17. 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

    THE PATIENT CAME IN COMPLAINING OF SWOLLEN AND INFLAMED. THE SURGEON REVIEWED THE PATIENT AND DETERMINED A REVISION WAS NEED. THE SURGEON WASHED AND CLEAN THE AREA THEN CHANGED THE LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794744 MPACT FLAT PE HC LINER Ø36/E FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 170979 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention