BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIP

    MDR report key: 3254186 · Received July 25, 2013

    Report

    Report Number
    1644408-2013-00390
    Event Type
    Other
    Date Received
    July 25, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    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 DEVICE LOOSENING AFTER 15.7 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 DEVICE LOOSENING. 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. (B)(4). THE ROOT CAUSE FOR THE DEVICE LOOSENING WAS NOT DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE CUP BEING LOOSE. THERE WAS ZERO BONE IN GROWTH ON THE SHELL WHEN THE CUP, LINER AND HEAD WERE REMOVED. THE SURGEON REPLACED THEM WITH A DJO HEAD AND A ZIMMER CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348688 HIP SHELL, HIP FLARED 56MM LPH ENCORE MEDICAL, L.P. 119741

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4), LOT 64751| (B)(4), LOT 158481