BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2851078 · Received November 19, 2012

    Report

    Report Number
    1644408-2012-00618
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 4.9 YEARS OF PATIENT USE. 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 IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. 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 NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 12TH COMPLAINT FOR THIS PART NUMBER: SEVEN DUE TO DISLOCATION, TWO DUE TO INFECTION, AND TWO FOR STABILITY/POOR JOINT ISSUES. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE OF THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE AND PATIENT ACTIVITY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY- THE PT SUFFERED CHRONIC DISLOCATION. THE ACETABULAR CUP¿S POSITION WAS ABOUT 50-60 DEGREES. THE SURGEON REMOVED THE SHELL AND LINER AND REPLACED WITH STRYKER IMPLANTS, AND CHANGED THE HEAD TO A 36 WITH A +3.5 OFFSET SLEEVE. THE PT WAS FIRST REVISED ON (B)(6) 2012, DURING WHICH THE ORIGINAL LINER, HEAD, AND INSERT IMPLANTED ON (B)(6) 2007 WERE REVISED AND REPLACED. THE ORIGINAL SHELL IMPLANTED ON (B)(6) 2007 WAS REMOVED AT THIS REVISION OF (B)(6) 2012 AS WELL AS THE HEAD AND INSERT IMPLANTED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP COCR HEAD KWA ENCORE MEDICAL, L.P. 638C1056

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 430-01-054, LOT 53869162| 411-00-000, LOT 902B1065| 933-36-254, LOT 53982084