BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP IMPLANT

    MDR report key: 8346384 · Received February 16, 2019

    Report

    Report Number
    1020279-2019-00592
    Event Type
    Injury
    Date Received
    February 16, 2019
    Date of Event
    January 23, 2019
    Report Date
    May 21, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, 26862 - FIRST REVISION: ALTHOUGH IT WAS REPORTED THAT THE METAL ION LEVELS WERE ELEVATED, NO LEVELS WERE PROVIDED, AND IT WAS REPORTED A PREOPERATIVE WORKUP FOR INFECTION WAS NEGATIVE. WITHOUT THE SUPPORTING LAB/PATHOLOGY RESULTS, IMAGING, AND/OR THE ANALYSIS OF THE EXPLANTED COMPONENTS, THE SOURCE OF THE ELEVATED LEVELS, LOOSENING, AND PAIN CANNOT BE CONFIRMED AND IT CANNOT BE CONCLUDED THAT THE REPORTED EVENTS/CLINICAL REACTIONS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT. ALSO, WITHOUT THE IMPLANTATION AND PREREVISION X-RAYS TO DETERMINE INITIAL IMPLANT ANATOMICAL PLACEMENT AND ANY MICRO-MOTION OVER TIME, THIS CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED ISSUE. THE PATIENT IMPACT BEYOND THE PAIN, REVISION, AND EXPECTED TRANSIENT POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. 229795/230947 - SECOND REVISION: ALTHOUGH THE SCRATCHES FOUND ON THE FEMORAL COMPONENT MAY BE CONSISTENT WITH RECURRENT DISLOCATIONS, WITHOUT AN ANALYSIS OF THE EXPLANTED COMPONENTS, ALL RELEVANT PATIENT MEDICAL HISTORY, OR PRE-REVISION X-RAYS, THE SOURCE OF THE RECURRENT DISLOCATIONS CANNOT BE CONFIRMED, AND IT CANNOT BE CONCLUDED THAT THE DISLOCATIONS WERE ASSOCIATED WITH A MALPERFORMANCE OF THE IMPLANT. THE PATIENT IMPACT BEYOND THE PAIN, REVISION, AND EXPECTED TRANSIENT POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECOND REVISION WAS PERFORMED TO REMOVE THE OXINIUM HEAD AND EMPERION SIZE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139482 HIP IMPLANT PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R