BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9181988 · Received October 11, 2019

    Report

    Report Number
    1818910-2019-108603
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    January 1, 2017
    Report Date
    September 24, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, "MONOBLOC IMPLANTS IN CEMENTLESS TOTAL HIP ARTHROPLASTY IN PATIENTS WITH LEGG-CALVEPERTHES DISEASE: A LONG-TERM FOLLOW-UP" WRITTEN BY ZE-YU LUO, HAO-YANG WANG, DUAN WANG, HUI PAN, FU-XING PEI1 AND ZONG-KE ZHOU PUBLISHED BY BMC MUSCULOSKELETAL DISORDERS LUO ET AL. BMC MUSCULOSKELETAL DISORDERS (2017) 18:386 DOI 10.1186/S12891-017-1748-1 IN 2017 WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE: " TO EVALUATE THE 10-YEAR OUTCOMES OF CEMENTLESS MONOBLOC THAS IN A GROUP OF CONSECUTIVE HIPS WITH LCPD." THE DATA WAS COMPILED FROM 71 PATIENTS (88 HIPS) RECEIVING THAS BETWEEN JUNE 2003 AND DECEMBER 2009 AND AVERAGE FOLLOW UP OF 10 YEARS. PRODUCTS UTILIZED WERE DEPUY PINNACLE CUPS FIXATED WITH TWO SCREWS AND CORAIL STEMS IN 61 HIPS AND TRILOCK STEMS IN THE REMAINING 27 HIPS. BEARINGS WERE COC FOR 78 HIPS, MOP IN 2 HIPS AND COP IN 8 HIPS. ADVERSE EVENTS: 2 INTRAOPERATIVE FEMORAL FRACTURE (TREATED WITH CERCLAGE WIRING), 2 POST-OPERATIVE TEMPORARY SCIATIC NERVE PARALYSIS (SELF RESOLVED BY FINAL FOLLOW UP), 2 HETEROTOPIC OSSIFICATION (NO IMPACT ON FUNCTION AND NO INTERVENTIONS REQUIRED), 1 REPORT OF THIGH PAIN AT LAST FOLLOW-UP (NO FURTHER INFORMATION PROVIDED),1 DISLOCATION (TREATED WITH CLOSED REDUCTION WITH NO FURTHER SEQUELAE). THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE EXACT QUANTITIES OF PRODUCTS INVOLVED AS PATIENTS MAY EXPERIENCE MORE THAN ONE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972044 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention