BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9254022 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112968
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    April 28, 2013
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    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 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, ""RETAINING WELL-FIXED CEMENTLESS STEM IN THE TREATMENT OF INFECTED HIP ARTHROPLASTY"" WRITTEN BY YOUNG-KYUN LEE, KEE HAENG LEE, JAE-HWI NHO, YONG-CHAN HA & KYUNG-HOI KOO PUBLISHED BY ACTA ORTHOPAEDICA 2013; 84 (3): 260¿264 PUBLISHED ONLINE 28 APRIL 2013 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO DETERMINE WHETHER INFECTION AFTER HIP ARTHROPLASTY CAN BE TREATED WITHOUT REMOVAL OF A WELL FIXED STEM. DATA WAS COMPILED FROM 19 PATIENTS IN 3 HOSPITALS (7 MEN AND 12 WOMEN, 19 HIPS RECEIVING A 2 STAGE REVISION TREATMENT FOR INFECTION FROM JANUARY 2005 TO APRIL 2010. IT IS NOTED THAT A TABLE ON PAGE 261 PROVIDES A LIST OF ALL PATIENTS WITH IDENTIFIERS AND IDENTIFIED PRODUCTS. EACH PATIENT WITH DEPUY PRODUCTS IS CAPTURED INDIVIDUALLY ON LINKED COMPLAINTS. ALL PATIENTS HAD ALL IMPLANTS EXPLANTED THEN RECEIVED AN ANTIBIOTIC IMPREGNATED SPACER FOR A VARIED DURATION OF TIME WITH BONE GRAFTING IF NECESSARY AND THEN FINAL STAGE OF NEW IMPLANTS THAT ARE NOT IDENTIFIED. THIS COMPLAINT CAPTURES CASE 8 A FEMALE (B)(6) WITH INITIAL AML STEM THAT RECEIVED IRRIGATION AND DEBRIDEMENT FOR INFECTION 39 MONTHS POST INITIAL IMPLANTATION FOLLOWED BY SPACER IMPLANTATION DURATION OF 3 MONTHS BEFORE RECEIVING NEW UNIDENTIFIED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047870 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention