BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/E

    MDR report key: 12467904 · Received September 14, 2021

    Report

    Report Number
    3005180920-2021-00752
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 20, 2021
    Report Date
    September 14, 2021
    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 01 SEPTEMBER 2021: LOT 140550: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2014. EXPIRATION DATE: 2019-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. 5 YEARS AND 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE MPACT FLAT LINER HC 32/E WITH A FLAT PE HC LINER Ø36/E. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363331 LINER: MPACT FLAT PE HC LINER 32/E HIP ACETABULAR INSERT LPH MEDACTA INTERNATIONAL SA 01.32.3244HCT 140550 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention