BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 7251039 · Received February 8, 2018

    Report

    Report Number
    3005180920-2018-00024
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 8, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 FEBRUARY 2018. LOT 171740: (B)(4) MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 REFERENCE 01.29.208 (K112115). LOT 173295: (B)(4) MANUFACTURED AND RELEASED ON 07 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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. CULTURES CAME BACK NEGATIVE. THE SURGEON REVISED THE HEAD AND LINER FOR CAUTIONARY MEASURES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99263 MPACT FLAT PE HC LINER Ø36/E FLAT LINER JWH MEDACTA INTERNATIONAL SA 171740 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention