BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 14014701 · Received April 5, 2022

    Report

    Report Number
    3005180920-2022-00224
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 5, 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 14 MARCH 2022 LOT 1909326:(B)(4). EXPIRATION DATE: 2024-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 MARCH 2022 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 184384 LOT 184384: (B)(4). EXPIRATION DATE: 2023-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4).

    Description of Event or Problem · 0

    AT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING GROIN PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048715 LINER: MPACT FLAT PE HC LINER Ø36/E HIP COCR BALL HEAD LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 1909326 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention