BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 8054906 · Received November 9, 2018

    Report

    Report Number
    3005180920-2018-00880
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    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 09 NOVEMBER 2018. LOT 179365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MAY 2018 . EXPIRATION DATE: 2023-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 REFERENCE 01.29.210. LOT 180544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2018. EXPIRATION DATE: 2023-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON 12 OCTOBER 2018 WE WERE INFORMED THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED A HEMATOMA WAS PRESENT. THE SURGEON PLANS TO WASHOUT THE HIP. UPDATE (B)(6) 2018: ON (B)(6) 2018 THE PATIENT WAS REVISED. THE SURGEON WASHED OUT THE HIP AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. UPDATE (B)(6) 2018: THE REASON OF HEMATOMA IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894888 MPACT FLAT PE HC LINER Ø36/F FLAT LINER LPH MEDACTA INTERNATIONAL SA 179365 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention