BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 8270061 · Received January 23, 2019

    Report

    Report Number
    3005180920-2019-00007
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 28, 2018
    Report Date
    January 23, 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 22 JANUARY 2019. LOT 179361: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 APRIL 2018 . EXPIRATION DATE:2023-04-13. 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: COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5 REFERENCE 01.25.023 (K072857). LOT 172867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 SEPTEMBER 2017. EXPIRATION DATE: 2022-09-03. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 MONTHS AND 11 DAYS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE A DISLOCATION OF THE HEAD FROM THE LINER. THE DISLOCATION OCCURED WHEN THE PATIENT RAISED HER LEG IN ORDER TO TIE HER SHOE. THE SURGEON REVISED THE CUP, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USED AN ANTERIOR APPROACH IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65220 MPACT FLAT PE HC LINER Ø32/E PE LINER LPH MEDACTA INTERNATIONAL SA 179361 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention