BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 14546086 · Received May 31, 2022

    Report

    Report Number
    3005180920-2022-00405
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 1, 2022
    Report Date
    May 31, 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 03 MAY 2022. LOT 2109538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2021. EXPIRATION DATE: 2026-07-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 03 MAY 2022. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2103149. LOT 2103149: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2021. EXPIRATION DATE: 2026-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679547 LINER: MPACT FLAT PE HC LINER Ø36/E LINER FLAT PE HC LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2109538 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention