BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA HIP

    MDR report key: 2823692 · Received October 25, 2012

    Report

    Report Number
    1644408-2012-00563
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LZO
    PMA / PMN Number
    K082844
    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 IDENTIFIED AS INSTABILITY AFTER 3.4 YEARS 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 FIRST COMPLAINT FOR THIS PART NUMBER. THE ROOT CAUSE FOR THE INSTABILITY 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 INSTABILITY SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE, IMPLANT SELECTION, OR 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 HAD INSTABILITY. THE SURGEON DECIDED TO REVISE THE HEAD AND INSERT A LONGER NECK LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA HIP CERAMIC HEAD - 4.0 LZO ENCORE MEDICAL, L.P. 53983248

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention