BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9451984 · Received December 11, 2019

    Report

    Report Number
    1818910-2019-122372
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    March 17, 2015
    Report Date
    November 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: 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. - ATTACHMENT: [(B)(4) LITERATURE ARTICLE. PDF, (B)(4) GUIDANCE(HIP).XLSX]

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿COMPARED FIXATION AND SURVIVAL OF 280 LATERALISED VS 527 STANDARD CEMENTLESS STEMS AFTER TWO YEARS (1¿7)¿ BY O. CANTIN, ET AL, PUBLISHED BY ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH (2015), VOL. 101, PP. 775-780, WAS REVIEWED. THE OBJECTIVES OF THIS STUDY WERE TO COMPARE CEMENTLESS LATERALIZED STEMS AND STANDARD STEMS OF IDENTICAL DESIGN IN TERMS OF RADIOLOGICAL BONY ON GROWTH AND SURVIVAL. THIS ARTICLE DOES NOT IDENTIFY THE CUPS, HEADS, OR ACETABULAR LINERS USED WITH THE CORAIL STEMS. IMPLANTED DEPUY PRODUCTS: CEMENTLESS CORAIL STANDARD KLA AND CEMENTLESS CORAIL LATERALIZED KHO STEMS. THE RESULTS FOR THE KHO LATERALIZED HAVE BEEN PREVIOUSLY REPORTED IN (B)(4) AND WILL THEREFORE NOT BE CAPTURED IN THIS COMPLAINT. THIS COMPLAINT WILL CAPTURE THE RESULTS ASSOCIATED WITH THE CORAIL STANDARD KLA STEM. RESULTS: THERE WERE NO REVISIONS OR INTERVENTIONS REPORTED FOR THE STANDARD KLA STEM. THERE WERE AN UNKNOWN NUMBER OF RADIOGRAPHICALLY IDENTIFIED MISPOSITIONED STEMS. THERE WERE INCIDENCES OF RADIOLUCENCIES NOTED WITHIN THE TEXT OF THIS ARTICLE. CAPTURED IN THIS COMPLAINT: CORAIL KLA STANDARD STEM: IMPLANT MISPOSITIONED. NO PATIENT CONSEQUENCES WERE NOTED FOR THE CORAIL KLA STEM. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250235 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KXA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1