BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2845065 · Received November 9, 2012

    Report

    Report Number
    1644408-2012-00589
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A PROBLEM WITH A NON-DJO SURGICAL STEM. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE 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 ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT. THE PART WAS DISPOSITIONED ACCEPT FOR TAPER ANGLE NONCONFORMANCE. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FOURTH COMPLAINT FOR THIS PART NUMBER: ONE DUE TO TRAUMA, ONE FOR PAIN, AND ONE DUE TO DISLOCATION. THIS IS THE SECOND COMPLAINT FOR THIS LOT NUMBER DUE TO TRAUMA. THE ROOT CAUSE FOR THE STEM PROBLEM WAS NOT DETERMINED WITH CONFIDENCE.

    Description of Event or Problem · 1

    REVISION SURGERY- THE SURGEON REPLACED THE ORIGINAL METAL-ON-METAL LINER WITH X-ALT. THIS WAS DUE TO A STEM ISSUE WITH COMPETITOR'S PRODUCT, NOT A DJO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP METAL-ON-METAL LINER-NEUTRAL, MP7 KWA ENCORE MEDICAL, L.P. 626631

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention (B)(4), LOT 819601