BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEAD Ø28X46

    MDR report key: 7706393 · Received July 20, 2018

    Report

    Report Number
    3005180920-2018-00523
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843631
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JULY 2018. LOT 175687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 DECEMBER 2017. EXPIRATION DATE: 2022-11-26. 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. REFERENCE 01.25.013 (K072857) COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5. LOT 174668: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 NOVEMBER 2017. EXPIRATION DATE: 2022-10-26. 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 1 MONTH AFTER PRIMARY. THE PATHOGEN CONFIRMED AS ENTEROCOCCUS FAECALIS. THE SURGEON WASHED OUT THE HIP AND REVISED THE BIPOLAR HEAD AND COCR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548742 BIPOLAR HEAD Ø28X46 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 175687 07630030843631

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention