BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2823689 · Received October 25, 2012

    Report

    Report Number
    1644408-2012-00562
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K953510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AN AGENT REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT PAIN. THE ORIGINAL SURGERY WAS PERFORMED ON OR ABOUT (B)(6) 2002. THE COMPONENTS WERE IN-VIVO APPROXIMATELY EIGHT YEARS AND TWO MONTHS AT THE TIME OF THE REVISION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO DJO SURGICAL FOR EXAMINATION. A VISUAL INSPECTION OF THE INCIDENT BIPOLAR HEAD, BIPOLAR POLY LINER, AND BIPOLAR SHELL SHOWED THEY WERE STILL ASSEMBLED. THE ARTICULATING SURFACE OF THE BIPOLAR SHELL IS IN GOOD CONDITION. THERE ARE VERY LIGHT SCRATCHES CONSISTENT WITH OVER EIGHT YEARS OF USE. THE CHAMFER AROUND THE POLY LINER HAS SOME SUBSURFACE WEAR AND IS CONSISTENT WITH PRODUCT USE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED TWO PARTS WERE SCRAPPED AT THE LATHE FOR THE BIPOLAR LINER FOR VISUAL NONCONFORMANCE, TWO PARTS OF THE BIPOLAR SHELL WERE FOUND TO BE NON-CONFORMING; ONE FOR A BURR THAT DID NOT CONFORM TO THE BREAK CORNERS SPECIFICATION AND ONE PART HAD TWO NON-CONFORMING DIMENSIONS. THE BURR WAS REWORKED AND THE SECOND PART WAS RETURNED TO THE VENDOR. THE NONCONFORMANCES DID NOT CONTRIBUTE TO THE COMPLAINT. THERE WERE NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE CERAMIC HEAD AND ALL CRITICAL DIMENSIONS AND SPECIFICATIONS WERE MET. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS FOUR COMPLAINTS AGAINST THE BIPOLAR ASSEMBLY FOR: A PACKAGING ISSUE, A WEAK POLY ENGAGEMENT, ONE DUE TO INFECTION, AND ONE FOR REPEATED DISLOCATION. THERE WERE THREE COMPLAINTS FOR THE CERAMIC HEAD; ONE FOR DISLOCATION, ONE FOR SHELL LOOSENING, AND ONE FOR LOOSENING OR CERAMIC HEAD FRACTURE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION IS PAIN AFTER EIGHT YEARS IN-VIVO. BIPOLAR HIP SYSTEMS ARE DESIGNED FOR PATIENTS WITH LOW ACTIVITY LEVELS. FACTORS WHICH CAN PRODUCE ACETABULUM PAIN INCLUDE: PATIENT ACTIVITY LEVEL AND ACETABULUM BONE AND/OR CARTILAGE DEGENERATION. ALL NECESSARY STEPS WERE IMPLEMENTED TO ENSURE A SAFE AND EFFECTIVE DEVICE WAS PROVIDED TO THE PATIENT. THERE IS NO EVIDENCE OF A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WHICH CONTRIBUTED TO THE NEED FOR A REVISION.

    Description of Event or Problem · 1

    REVISION SURGERY- THE PT WAS REVISED FROM A BIPOLAR TO A TOTAL HIP, DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP BIPOLAR SHELL KWY ENCORE MEDICAL, L.P. 834991

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 400-01-291, LOT 784961