BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVALATION HIP

    MDR report key: 2931640 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00025
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K083651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A LOOSE FEMORAL COMPONENT AFTER ONE YEAR OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. 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 SECOND COMPLAINT FOR THIS PART NUMBER, ONE OTHER FOR DEVICE LOOSENING. THE ROOT CAUSE OF THE LOOSE COMPONENT WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. 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'S STEM WAS LOOSE, BUT NOT INFECTED. THE IMPLANT JUST DID NOT TAKE. THE SURGEON PULLED ALL OF THE DJO PRODUCT OUT OF THE PATIENT AND REPLACED IT WITH A ZIMMER HIP STEM AND PRODUCT. THE SURGEON REMOVED THE HEAD, SLEEVE, AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34441 REVALATION HIP REVELATION MICROMAX, STD. NECK KWA ENCORE MEDICAL, L.P. 252C1017

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4), LOT 54042137| (B)(4), LOT 903B1048| (B)(4), LOT 53989188| (B)(4), LOT 638C1014