BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 7302570 · Received February 28, 2018

    Report

    Report Number
    3005180920-2018-00100
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 29, 2018
    Report Date
    February 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018: LOT 171737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2017. EXPIRATION DATE: 2022-07-06 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 32 SIZE L +4 REFERENCE 01.29.206 (K112115) LOT 161055: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2016. EXPIRATION DATE: 2021-05-01 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 PERFORMED DUE TO SIGNS OF INFECTION 19 DAYS AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE HIP AND SWAPPED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148480 MPACT FLAT PE HC LINER Ø32/E FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 171737 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention