BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2931621 · Received January 22, 2013

    Report

    Report Number
    1644408-2013-00009
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K935263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS A DISLOCATION AFTER 8.1 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. 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 AND WAS KEPT BY THE HOSPITAL. 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 SIXTH COMPLAINT FOR THIS PART NUMBER: FOUR DUE TO DISLOCATION, ONE FOR INSTABILITY, AND ONE DUE TO PAIN. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO INSTABILITY. 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 AND 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 WAS UNSTABLE AND DISLOCATING. THE SURGEON REPLACED THE 32MM HEAD WITH A 40MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30968 FMP HIP COCR HEAD +4.0 JDI ENCORE MEDICAL, L.P. 214512

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention