BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/G

    MDR report key: 7637644 · Received June 26, 2018

    Report

    Report Number
    3005180920-2018-00465
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JUNE 2018. LOT 174526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 NOVEMBER 2017. EXPIRATION DATE: 2022-11-14. 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. OTHER DEVICE INVOLVED: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 REFERENCE 01.29.208 (K112115). LOT 172266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-21. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT 2 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481593 MPACT FLAT PE HC LINER Ø36/G FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 174526 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention