BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2640373 · Received June 28, 2012

    Report

    Report Number
    1644408-2012-00331
    Event Type
    Other
    Date Received
    June 28, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2012 AN AGENT INFORMED DJO SURGICAL THAT A PATIENT HAD A REVISION SURGERY INVOLVING A 38MM METAL ON METAL ACETABULAR LINER. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT. THERE WAS NO INFORMATION PROVIDED IN THIS COMPLAINT RELATING TO PATIENT CONTRAINDICATIONS OR PHYSICAL ACTIVITY LEVEL WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. 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 RECORD SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. ALL COMPONENTS MET CRITICAL DIMENSIONS AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FROM DJO SURGICAL. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS 17 PRIOR COMPLAINTS ASSOCIATED WITH THIS PART NUMBER, ALL INVOLVING OTHER LOT NUMBERS. THE ROOT CAUSE OF THIS FAILURE INVESTIGATION IS LIMITED IN SCOPE SINCE THE PRODUCTS FROM THE REVISION SURGERY WERE NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. THERE WERE NO INDICATIONS OF A DESIGN, MANUFACTURING, OR MATERIAL DEFECT. THE COMPLAINT STATES THE SUBJECT DEVICE WAS REVISED DUE TO WEAR WHICH COULD BE CAUSED BY A NUMBER OF FACTORS UNRELATED TO DESIGN AND MANUFACTURE SUCH AS: PATIENT ACTIVITY LEVEL, WEIGHT, FOREIGN BODY INTERACTION, IMPROPER IMPLANT ALIGNMENT, AND TRAUMA. NONE OF THESE CONDITIONS WERE REPORTED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON SUGGESTED THAT THERE WAS A PROBLEM WITH THE BEARING SURFACE. THE POLY FAILED, DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL, MP9 KWA ENCORE MEDICAL, L.P. 53862175

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 497-38-000, LOT 53862505| 411-00-700, LOT 53878317