BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9474834 · Received December 16, 2019

    Report

    Report Number
    1818910-2019-121176
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    September 17, 2012
    Report Date
    November 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿PRIMARY AND REVISION THA USING A STEMLESS METAPHYSEAL-LOADING IMPLANT ABOVE DISTORTED PROXIMAL FEMORAL ANATOMY¿ BY PETER S. YOUNG, ET AL, PUBLISHED BY HIP INTERNATIONAL (2012), PP. 40-45, DOI: 10.5301/HIP.2012.10425, WAS REVIEWED. THE AUTHORS PRESENT SEVEN PATIENTS WITH DISTORTED PROXIMAL FEMORAL ANATOMY OR FAILED HIP ARTHROPLASTY IN WHOM A SHORT, METAPHYSEAL LOADING IMPLANT WAS UTILIZED. CASE 1-CASE 6 WERE REPORTS OF SUCCESSFUL PRIMARY THAS WITH NO PATIENT CONSEQUENCES AND WILL NOT BE INCLUDED IN THIS COMPLAINT. THIS COMPLAINT WILL CAPTURE CASE 7. THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THE MANUFACTURER OF THE CUPS, HEADS, AND LINERS USED IN CASE 7. (B)(6) MALE IMPLANTED WITH A CHARNLEY FEMORAL STEM. CHARNLEY STEM WAS REVISED TO A SOLUTION CALCAR STEM 5 YEARS AFTER INDEX THA DUE TO ASEPTIC LOOSENING. SEVERAL YEARS LATER, THE PATIENT PRESENTED WITH SEVERE PAIN SECONDARY TO A FRACTURE OF THE SOLUTION CALCAR STEM. THE FRACTURED STEM WAS REVISED TO A PROXIMA METAPHYSEAL FEMORAL STEM. THE PATIENT HAD A GOOD OUT COME WITH NO COMPLICATIONS AT FINAL FOLLOW-UP. CAPTURED IN THIS COMPLAINT: CHARNLEY FEMORAL STEM: IMPLANT LOOSENING. SOLUTION CALCAR STEM: IMPLANT FRACTURE POST-OP. PATIENT HARMS: PAIN, SURGICAL INTERVENTION, MEDICAL DEVICE REMOVAL, INADEQUATE OSSEOINTEGRATION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269996 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention