BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION HIP

    MDR report key: 3113697 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00150
    Date Received
    May 15, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS PAIN AFTER 6.5 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION INITIAL OR PROLONGED, DISABILITY OR PERMANENT DAMAGE, AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED TWO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE LINER: (B)(4) DUE TO DIMENSIONAL ISSUES AND (B)(4) FOR IMPROPER ASSEMBLY OF THE COMPONENTS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 22ND COMPLAINT FOR THIS PART NUMBER: THREE DUE TO DISLOCATION, THREE FOR EXCESSIVE WEAR, TWO DUE TO PAIN, FIVE DUE TO INFECTION, TWO FOR DEVICE LOOSENING, ONE FOR INSTABILITY, TWO FOR DISSOCIATION, TWO FOR METAL SENSITIVITY, AND ONE DUE TO DISCOMFORT. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE PAIN, OSTEOLYSIS, AND METALLOSIS CANNOT BE DETERMINED WITH CONFIDENCE SINCE NO PARTS WERE RETURNED FOR INSPECTION. THERE ARE SEVERAL FACTORS THAT CAN CONTRIBUTE TO OSTEOLYSIS INCLUDING: AGE, DISEASE, MEDICAL CONTRAINDICATION, DISTAL LOADING OF THE IMPLANT, OR INSUFFICIENT PROXIMAL BONE BEFORE THE PRIMARY SURGERY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD A TOTAL HIP ARTHROPLASTY IN 2006. THE PATIENT WENT IN TO SEE THE DOCTOR DUE TO EXPERIENCING PAIN. UPON REVIEW OF THE X-RAYS, THE DOCTOR FOUND OSTEOLYSIS AROUND THE FEMORAL COMPONENT. IN SURGERY, THE STEM WAS LOOSE AND A GOOD AMOUNT OF METALLOSIS WAS OBSERVED. THE SURGEON CONVERTED THE PATIENT TO A POLY LINER AND REPLACED THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215561 FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL, MP9 KWA ENCORE MEDICAL, L.P. 275732

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 426-00-050, LOT 1240A| 411-00-000, LOT 53783462| 497-38-000, LOT 53797690