BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR HEAD Ø28X52

    MDR report key: 10023935 · Received May 5, 2020

    Report

    Report Number
    3005180920-2020-00270
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 4, 2020
    Report Date
    May 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843754
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 APRIL 2020: LOT 1904863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2019. EXPIRATION DATE: 2024-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED IN THE COMPLAINT: BATCH REVIEW PERFORMED ON 17 APRIL 2020: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT 1905316: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2019. EXPIRATION DATE: 2024-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 99 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE BIPOLAR COMPONENT FROM THE BALL HEAD. THE CAUSE OF THE DISLOCATION IS UNKNOWN. 1 MONTH AFTER PRIMARY SURGERY THE SURGEON REVISED THE BIPOLAR HEAD 52MM/28 WITH A BIPOLAR HEAD 53MM/28 AND LEFT THE 28MM COCR HEAD S AND QUADRA-P STD. SIZE 4 STEM AS THEY WERE STABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486600 BIPOLAR HEAD Ø28X52 HIP BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2852 1904863 07630030843754

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention