BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER MPACT FLAT PE HC Ø32/E

    MDR report key: 8377332 · Received February 28, 2019

    Report

    Report Number
    3005180920-2019-00098
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 28, 2019
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 FEBRUARY 2019: LOT 182610: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-03. 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. AN ADDITIONAL ITEM WAS INVOLVED IN THE COMPLAINT. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 184378 (K112115) : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2018. EXPIRATION DATE: 2023-09-26. 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 (I&D AND HEAD AND LINER REVISION) DUE TO SIGNS OF INFECTION TWO WEEKS AFTER THE PRIMARY. A WASHOUT WAS THEN PERFORMED FIVE DAYS AFTER REVISION SURGERY DUE TO HIGH LEVEL OF BACTERIA (KLEBSIELLA PNEUMONIAE). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173062 LINER MPACT FLAT PE HC Ø32/E HIP PE HC LINER LPH MEDACTA INTERNATIONAL SA 182610 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention