BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMA HIP

    MDR report key: 2823702 · Received October 25, 2012

    Report

    Report Number
    1644408-2012-00570
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    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 SYMPTOMS RELATED TO THE LENGTH OF THE PROXIMAL AFTER 8.7 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 FIRST COMPLAINT FOR THIS PART NUMBER. THE ROOT CAUSE FOR THE LENGTH ISSUE 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 LENGTH OF THE PROXIMAL BODY NEEDED TO BE LENGTHENED FROM A 20MM TO A 80MM. THE SURGEON ADDED A 7MM OFFSET AS WELL. THE OUTCOME WAS REVISING THE PROXIMAL BODY, HEAD, AND SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMA HIP REVISION BODY, LAT. KWY ENCORE MEDICAL, L.P. 1106793

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 411-00-350, LOT 931B1017| 497-40-000, LOT 641C1007