BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINEAR HIP

    MDR report key: 3214090 · Received July 3, 2013

    Report

    Report Number
    1644408-2013-00358
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K991325
    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 IDENTIFIED AS "THE PATIENT'S HIP WAS LOOSE" AFTER SIX YEARS 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 DISPOSED OF AT THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT: (B)(4) INVOLVED A DOCUMENTATION ERROR OF A LOT AND THE ERROR WAS CORRECTED. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT. THE ROOT CAUSE FOR THE LOOSENING COULD NOT BE 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'S HIP WAS LOOSE. THE SURGEON REMOVED ALL IMPLANTS EXCEPT THE SHELL AND SCREWS. THE SURGEON REPLACED THE LINER FROM DJO. THE REST OF THE IMPLANTS WERE REPLACED BY ANOTHER COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306409 LINEAR HIP LINEAR POROUS COATED HIP STEM, SZ 5 LPH ENCORE MEDICAL, L.P. 950531

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 497-34-000, LOT 53842603| 499-34-008, LOT 53842580| 411-00-000, LOT 53845884