BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLP HIP

    MDR report key: 2931611 · Received January 22, 2013

    Report

    Report Number
    1644408-2013-00020
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K052320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A PERIPROSTHETIC FRACTURE AFTER 3.6 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 THIRD COMPLAINT FOR THIS PART NUMBER: ONE DUE TO WEAR AND ONE FOR NO BONE IN-GROWTH. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE PERIPROSTHETIC FRACTURE 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 PT HAD A PERIPROSTHETIC FRACTURE. THE SURGEON REMOVED THE CLP SLEEVE AND HEAD AND REPLACED THEM WITH LIMA SLEEVE, HEAD, STEM, AND BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29491 CLP HIP LATERAL OFFSET STEM JDI ENCORE MEDICAL, L.P. 53867119

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4), LOT 90381056| (B)(4), LOT 638C1054