BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9297841 · Received November 8, 2019

    Report

    Report Number
    1818910-2019-111725
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    September 16, 2014
    Report Date
    October 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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, "OUTCOME OF AN ULTRASHORT METAPHYSEAL-FITTING ANATOMIC CEMENTLESS STEM IN HIGHLY ACTIVE OBESE AND NON-OBESE PATIENTS" WRITTEN BY YOUNG-HOO KIM, JANG-WON PARK, AND JUN-SHIK KIM PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (SICOT) (2015) 39:403¿409. DOI 10.1007/S00264-014-2520-X PUBLISHED ONLINE 16 SEPTEMBER 2014 WAS REVIEWED. THE ARTICLE'S PURPOSE: "THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE CLINICAL AND RADIOGRAPHIC RESULTS AND COMPLICATION RATES AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY USING AN ULTRASHORT FEMORAL STEM IN HIGHLY ACTIVE [UNIVERSITY OF (B)(6)) ACTIVITY LEVEL ABOVE 8 POINTS] OBESE AND NON-OBESE PATIENTS." DATA WAS COMPILED FROM 108 PATIENTS WITH 138 HIPS INVOLVED IN OBESE GROUP AND 125 PATIENTS WITH 168 HIPS INVOLVED IN NON OBESE GROUP WITH MEAN FOLLOW UP OF 7.4 YEARS (OBESE GROUP) AND 7.5 YEARS (NON-OBESE GROUP). DEPUY PRODUCTS UTILIZED: PINNACLE CUP, PROXIMA STEM, COC BEARING SURFACES - ALL DEPUY PRODUCTS IN ALL HIPS. ADVERSE EVENTS FOR BOTH GROUPS: CLICKING OR SQUEAKING SOUND (NO INTERVENTIONS), DVT (LOCATED IN FEMORAL AND EXTERNAL ILIAC VEINS AND TREATED WITH INFERIOR VENA CAVA UMBRELLA), INTRAOPERATIVE UNDISPLACED LINEAR CALCAR FRACTURE (TREATED WITH CERCLAGE CABLE WITHOUT SEQUELAE), DISLOCATION (TREATED WITH CLOSED REDUCTION AND ABDUCTION BRACE FOR 3 MONTHS WITHOUT REOCCURRENCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092981 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention