BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/G

    MDR report key: 8150507 · Received December 11, 2018

    Report

    Report Number
    3005180920-2018-00981
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 11, 2018
    Report Date
    December 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 DECEMBER 2018. LOT 168474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEBRUARY 2017. EXPIRATION DATE: 2022-02-09. 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. OTHER DEVICE INVOLVED: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 REFERENCE 01.29.210; LOT 180544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2018. EXPIRATION DATE: 15.05.2023-05-15. 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 SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER DUE TO INFECTION 19 DAYS AFTER PRIMARY SURGERY. THE PATHOGEN IS PSEUDOMONAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993312 MPACT FLAT PE HC LINER Ø36/G FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 168474 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention