BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR HIP

    MDR report key: 5046780 · Received September 1, 2015

    Report

    Report Number
    1644408-2015-00498
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    UDI-DI
    888912077859
    PMA / PMN Number
    K991325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMOVE THE STEM AND REPLACE WITH A COMPETITORS STEM. IT WAS REPORTED THAT A POST-OPERATIVE X RAY FOUND A BONE FRACTURE AT THE STEM CIRCUMFERENTIAL. AS THE AFFECTED LIMB WAS PARALYZED ORIGINALLY, THE SURGEON DECIDED TO FIX IT BY BRACE INSTEAD OF REVISION SURGERY. THE FOLLOW UP X RAY TAKEN ON 6 JULY SHOWED THE STEM'S SINKING. REVISION SURGERY WAS IMPLEMENTED ON (B)(4) 2015 TO REMOVE THE STEM AND REPLACE WITH A COMPETITORS STEM. NO INFORMATION IS AVAILABLE ABOUT PATIENT BONE CONDITION, OPERATING PROCEDURE, OR OTHER FACTORS THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS NOT AVAILABLE FOR USE. THE REVISION SURGERY WAS IMPLEMENTED TO REMOVE THE STEM AND REPLACE WITH A COMPETITORS STEM. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS (DHRS) EVIDENCES THAT ALL CRITICAL DIMENSIONS AND SPECIFICATIONS WERE MET WHEN RELEASED FROM DJO SURGICAL. THE LENGTH OF THE SIZE 9 IMPLANT IS 5.553" WITH AN +.020" / -.035" TOLERANCE; PER THE COMPLETED IS12642 IN THE DHR, THE INCIDENT IMPLANT MEASURES BETWEEN 5.535 AND 5.546 WHICH IS WELL WITHIN THE SPECIFICATION LIMITS. IN ADDITION, 100% OF THE STEMS IN THE LOT ARE INSPECTED TO THE APPROPRIATE OVERLAY IN THE MEDIAL-LATERAL AND ANTERIOR-POSTERIOR VIEWS. THE DHR EVIDENCES THAT ALL STEMS IN THE LOT MET THE SPECIFIED DIMENSIONAL TOLERANCE BANDS IN THESE OVERLAY VIEWS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THERE ARE 55 COMPLAINTS LODGED AGAINST THE LINEAR HIP STEM FAMILY, IN WHICH 10 COMPLAINTS CORRESPOND TO PART # 425-01-009. THERE ARE 6 COMPLAINTS FOR THE ENTIRE LINEAR HIP STEM FAMILY RELATED TO SIMILAR EVENTS OF THE STEM FRACTURE INDEPENDENT OF TRAUMA. COMPLAINT HISTORY DOES NOT INDICATE AN ADVERSE TREND. THE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED WITH CONFIDENCE BECAUSE THE INCIDENT HIP STEM WAS NOT RETURNED. THE CAUSE FOR SUBSIDENCE AND PERI-PROSTHETIC FRACTURE IS OFTEN BONE LOSS AND POOR BONE QUALITY, WHICH MAY HAVE BEEN CAUSED BY THE PATIENT'S PARALYSIS IN THIS LIMB. THERE WAS NO EVIDENCE THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THIS COMPLAINT. FURTHER INVESTIGATION CAN BE PERFORMED ONLY IF THE INFORMATION REGARDING PATIENT'S BONE QUALITY, PHYSIOLOGY AND X-RAYS OF PROSTHESIS OR SURGICAL REPORTS ARE PROVIDED.

    Description of Event or Problem · 1

    REVISION SURGERY - THE POST-OPERATIVE X- RAY FOUND A BONE FRACTURE AT THE STEM CIRCUMFERENTIAL. AS THE AFFECTED LIMB WAS PARALYZED ORIGINALLY, THE SURGEON DECIDED TO FIX IT BY A BRACE INSTEAD OF A REVISION SURGERY. THE OPERATION WAS COMPLETED SUCCESSFULLY. THE SURGEON IS NOT SURE WHEN THIS HAPPENED. THE FOLLOW UP X- RAY TAKEN ON (B)(6) 2015 SHOWED THE STEM'S SINKING. THE REVISION SURGERY WAS IMPLEMENTED ON (B)(6) 2015 TO REMOVE THE STEM AND REPLACE IT WITH A COMPETITOR'S STEM. THE EXTRACTED IMPLANT WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578317 LINEAR HIP STEM, HIP, FEMORAL, LINEAR SIZE9 STD. REDUCED NECK LPH ENCORE MEDICAL, L.P. 062C1167 888912077859

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention