BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR HIP

    MDR report key: 2781807 · Received October 5, 2012

    Report

    Report Number
    1644408-2012-00535
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE SURGEON PERFORMED TWO LINEAR TOTAL HIPS TODAY. ONE OF BOTH CASES, THE ACTUAL IMPLANT SAT PROUD COMPARED TO THE BROACH. IT IS NOT UNCOMMON FOR THE IMPLANT TO SEAT ONE OR TWO MM PROUD AT TIMES. HOWEVER, IN BOTH CASES TODAY, THE STEMS WERE PROUD MORE THAN THE USUAL. IN THE FIRST CASE, THE STEM WAS FOUR MM PROUD AND THE SECOND CASE THE STEM WAS SIX MM PROUD. THERE WAS NO SOFT TISSUE CAUGHT BETWEEN THE STEM AND THE BONE. THE SURGEON HAS BEEN USING THE LINEAR STEM FOR SEVERAL YEARS AND IS VERY FAMILIAR WITH IT. IN BOTH CASES, HE USED A -3.5 NECK WHICH LIMITED OPTIONS FOR MAKING UP FOR THE EXTRA LENGTH CAUSED BY STEM SITTING PROUD. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS NOT AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION AND WAS LEFT IN THE PATIENT. 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 ONE COMPLAINT FOR THIS PART NUMBER DUE TO THE STEM SINKING FURTHER THAN THE BROACH. VARIATIONS IN PATIENT ANATOMY AND SURGICAL TECHNIQUE CAN INFLUENCE THE OPENING CREATED IN THE BONE WHICH DIRECTLY AFFECTS THE PRESS FIT. A REVIEW OF THE COMPLAINT DATABASE SHOWS TWELVE COMPLAINTS FOR THE LINEAR STEM FAMILY REGARDING FIT. TEN OF THESE COMPLAINTS DEAL WITH SUBSIDING STEMS. THE ONLY TWO THAT DEAL WITH A PROUD FIT ARE FROM THE SAME DOCTOR AND PATIENT. ONE BROACH THAT WAS RETURNED FROM THESE COMPLAINTS WAS FOUND TO CONFORM TO ALL PRINT DIMENSIONS. THIS INVESTIGATION IS LIMITED IN SCOPE SINCE NONE OF THE STEMS HAVE BEEN RETURNED FOR EVALUATION. THE STEM RELATED TO THIS PRODUCT COMPLAINT MET ALL MANUFACTURING REQUIREMENTS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    PRIMARY SURGERY: THE SURGEON PERFORMED TWO LINEAR HIP SURGERIES (SEE MDR 534), AND IN BOTH CASES THE ACTUAL IMPLANT SAT PROUD COMPARED TO THE BROACH. ACCORDING TO THE AGENT, IT IS NOT UNCOMMON FOR THE IMPLANT TO SEAT 1 OR 2 MM PROUD AT TIMES, HOWEVER, IN BOTH OF THESE CASES, THE STEMS WERE PROUD MORE THAN USUAL. IN THIS PARTICULAR CASES, THE STEM WAS 6MM PROUD. THIS WAS NOT THE RESULT OF SOFT TISSUE CAUGHT BETWEEN THE STEM AND BONE. BOTH THE SURGEON AND AGENT ARE VERY FAMILIAR WITH THE LINEAR STEM, AND COULD NOT COME TO A CONCLUSION AS TO WHY THIS WOULD BE AN ISSUE. IN BOTH CASES, THE SURGEON USED A -3.5MM NECK, WHICH LIMITED THE OPTIONS FOR MAKING UP THE EXTRA LENGTH CAUSED BY STEM SITTING PROUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR HIP LATERAL OFFSET STEM LPH ENCORE MEDICAL, L.P. 106C1027

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other