BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BONE CEMENT

    MDR report key: 9214100 · Received October 21, 2019

    Report

    Report Number
    1818910-2019-110180
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    April 13, 2013
    Report Date
    September 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    PRODUCT COMPLAINT # (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, "REVISION TOTAL HIP REPLACEMENT WITH A CEMENTED LONG FEMORAL COMPONENT: MINIMUM 9-YEAR FOLLOW-UP RESULTS" WRITTEN BY KAZUTAKA SO, YUTAKA KURODA, SHUICHI MATSUDA, AND HARUHIKO AKIYAMA PUBLISHED BY ARCH ORTHOP TRAUMA SURG (2013) 133:869¿874 DOI 10.1007/S00402-013-1733-6 PUBLISHED ONLINE 13 APRIL 2013 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE: "THE AIM OF THIS STUDY WAS TO ANALYZE THE LONG-TERM RESULTS OF REVISION THR USING A CEMENTED LONG FEMORAL COMPONENT. PATIENT-RELATED AND TECHNIQUE-RELATED FACTORS WERE INVESTIGATED WITH RESPECT TO RADIOLOGICAL AND CLINICAL FINDINGS." THE DATA WAS COMPILED FROM 33 PATIENTS (34 HIPS) WITH 4 MEN AND 29 WOMEN WITH MEAN AGE OF 64.4 YEARS AND A MEAN FOLLOW UP DURATION OF 11.3 YEARS. DEPUY PRODUCTS UTILIZED IN ORIGINAL THRS: CHARNLEY STEM (22 HIPS), HASTING (1). ALL OTHERS WERE NON-DEPUY. THE INITIAL IMPLANTS WERE REVISED DUE TO ACETABULAR LOOSENING OR WEAR. NO INFORMATION PROVIDED FOR ACETABULAR COMPONENTS AS THE ARTICLE FOCUSES ON THE FEMORAL COMPONENT ONLY. AS SOME OF THE CHARNLEY STEMS MAY HAVE BEEN MONOBLOCK STYLE THE FEMORAL HEAD QUANTITY CANNOT BE ACCURATELY DETERMINED. NO INDICATION IF FEMORAL HEAD WAS NOTED WITH WEAR AS THE ARTICLE DOES NOT PROVIDE ANY INFORMATION ON ACETABULAR COMPONENTS. THE ARTICLE CLARIFIES THAT ALL FEMORAL COMPONENTS WERE EXPLANTED AND REPLACED WITH LONG STEM FEMORAL COMPONENTS. DEPUY PRODUCTS UTILIZED FOR REVISION WITH LONG STEM FEMORAL COMPONENT: ELITE PLUS (2). IT IS NOTED THAT DEPUY CEMENT CMW3 OR ENDURANCE CEMENT WAS UTILIZED. NO STEM RE-REVISION WAS REQUIRED. ADVERSE EVENTS NOTED: INTRAOPERATIVE PERFORATION OF THE FEMORAL CORTEX, POST-OPERATIVE DISLOCATION, DVT, PERIPROSTHETIC FEMORAL FRACTURE (1 YEAR POST OP), FOCAL PERIPROSTHETIC OSTEOLYSIS BY RADIOGRAPHIC IMAGING ONLY. THE ARTICLE DOES NOT MENTION DEBRIS AS THE OSTEOLYSIS WAS ONLY DETECTED RADIOGRAPHICALLY AND NO LONG STEMS REQUIRED REVISION. ONE IDENTIFIED PATIENT WITH A CHARNLEY STEM IS CAPTURED ON A LINKED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009056 UNKNOWN BONE CEMENT BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention