BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9258397 · Received October 30, 2019

    Report

    Report Number
    1818910-2019-113208
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    November 7, 2016
    Report Date
    October 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE LITERATURE ARTICLE ENTITLED, "TOTAL HIP ARTHROPLASTY USING A MONOBLOC CEMENTLESS FEMORAL STEM FOR PATIENTS WITH CHILDHOOD PERTHES¿ DISEASE" WRITTEN BY K. H. LEE, W-L. JO, Y. C. HA, Y. K. LEE, S. B. GOODMAN, AND K. H. KOO PUBLISHED BY THE BONE AND JOINT JOURNAL ACCEPTED BY PUBLISHER 7 NOVEMBER 2016 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO EVALUATE PATIENTS WHO HAD UNDERGONE THA BECAUSE OF PERTHES' DISEASE USING MONOBLOC CEMENTLESS STEMS WITH A MINIMUM FIVE-YEAR FOLLOW-UP. DATA WAS COMPILED FROM 68 PATIENTS (68 HIPS) (35 MEN AND 33 WOMEN WITH A MEAN AGE OF 48 YEARS) WHO UNDERWENT THA BETWEEN JUNE 2002 AND DECEMBER 2008 FOR OSTEOARTHRITIS SECONDARY TO CHILD-HOOD PERTHES' DISEASE WITH A MEAN FOLLOW UP FOR 8.5 YEARS (RANGE 5.2 TO 10). DEPUY PRODUCTS UTILIZED: 20 PATIENTS FROM THE GROUP RECEIVED PINNACLE CUPS, CORAIL STEMS WITH COC BEARING SURFACES. ADVERSE EVENTS: PROXIMAL FEMUR FRACTURE WHILE STEM BEING IMPLANTED TREATED BY CERCLAGE WIRING, RADIOGRAPHIC FINDINGS OF CORTICAL HYPERTROPHY AROUND TIP OF STEM, RADIOGRAPHIC FINDINGS OF RADIOLUCENT LINES, AND RADIOGRAPHIC HETEROTOPIC OSSIFICATION. NO REVISIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049626 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KXA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention