BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 13951067 · Received March 30, 2022

    Report

    Report Number
    3005180920-2022-00210
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 MARCH 2022 LOT 2114162: (B)(4). EXPIRATION DATE: 2026-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). ADDITIONAL COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2109346:(B)(4). EXPIRATION DATE: 2026-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE (B)(4).

    Description of Event or Problem · 0

    AT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698915 LINER: MPACT FLAT PE HC LINER Ø36/E HIP ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2114162 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention