BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDACTA BIPOLAR HEADS

    MDR report key: 2652141 · Received June 26, 2012

    Report

    Report Number
    3005180920-2012-00031
    Event Type
    Injury
    Date Received
    June 26, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 26, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    KWY
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW; MEDACTA BIPOLAR HEAD 28/44 - REF. (B)(4)/ LOT 110614 ((B)(4) HEADS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECS VALID AT THE TIME OF MFG. TWENTY FIVE BIPOLAR HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. IT WAS REPORTED THAT THE PT HAD PAIN DUE TO DEGENERATIVE CHANGES AT THE CARTILAGE SURFACE AND, FOR THIS REASON, A TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE ROOT CAUSE OF THE EVENT IS HIGHLY LIKELY RELATED TO THE BONE CONDITIONS OF THE PT, THAT CHANGE AFTER THE ORIGINAL HEMIARTHROPLASTY SURGERY, REQUIRING THE REPLACEMENT OF THE BIPOLAR HEAD WITH A TOTAL HIP ARTHROPLASTY. THIS IS A FACT QUITE COMMON IN HEMIARTHROPLASTY.

    Description of Event or Problem · 1

    PT HAD PAIN DUE TO DEGENERATIVE CHANGES AT THE CARTILAGE SURFACE. REVISION OF MEDACTA BIPOLAR HEAD ABOUT (B)(6) MONTHS POST HEMIARTHROPLASTY SURGERY: A TOTAL HIP ARTHROPLASTY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDACTA BIPOLAR HEADS BIPOLAR HEAD 28 / 44 KWY MEDACTA INTERNATIONAL, SA 110614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention