BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 14208038 · Received April 26, 2022

    Report

    Report Number
    3005180920-2022-00287
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    March 27, 2022
    Report Date
    April 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 APRIL 2022. LOT 2006534: (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 26 APRIL 2022. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2006688 LOT 2006688: (B)(4). EXPIRATION DATE: 2025-SEP-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027306 LINER: MPACT FLAT PE HC LINER Ø32/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3244HCT 2006534 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention