BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9143446 · Received October 1, 2019

    Report

    Report Number
    1818910-2019-106903
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    March 11, 2008
    Report Date
    September 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. CORRECTED: H6. 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. 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

    PRODUCT COMPLAINT # ==> (B)(4). ((B)(4)) USED TO CAPTURE SURGICAL INTERVENTION. ADDITIONAL NARRATIVE:  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 JOINT REPLACEMENT IN HIV POSITIVE PATIENTS" WRITTEN BY BJOERN HABERMANN, CHRISTIAN EBERHARDT, AND ANDREAS A. KURTH PUBLISHED BY JOURNAL OF INFECTION (2008) 57, 41E46 DOI:10.1016/J.JINF.2008.01.045 ON 11 MARCH 2008 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE FOCUSES ON RESULTS OF JOINT REPLACEMENTS FOR HIV POSITIVE PATIENTS. IT IS NOTED THAT HIP REPLACEMENTS UTILIZED DEPUY EUROFORM STEMS AND THE ADVERSE EVENT OF INFECTION WAS NOTED IN 5 EVENTS TREATED WITH REVISIONS AND ANTIBIOTIC THERAPY. THE ARTICLE IDENTIFIES THE ACETABULAR COMPONENTS AS NON DEPUY IMPLANTS BUT NO CLARIFICATION OF FEMORAL HEADS. ALSO NOTED IS A CASE OF A KNEE IMPLANT WITH DEPUY PFC SIGMA THAT REQUIRED EXPLANATION DUE TO INFECTION AND REPLACED WITH NON DEPUY PRODUCTS. THE ARTICLE CLARIFIES BONE CEMENT UTILIZED IN ALL PROCEDURES WAS A NON-DEPUY ANTIBIOTIC CEMENT. THE ARTICLE DOES NOT CLARIFY IF THE PATELLA WAS RESURFACED FOR THE KNEE IMPLANT. ADVERSE EVENT: INFECTION. IMPACTED PRODUCTS: DEPUY EUROFORM STEM, DEPUY SIGMA FEMORAL, DEPUY SIGMA TIBIAL TRAY, DEPUY SIGMA TIBIAL INSERT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937108 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention