BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BONE CEMENT

    MDR report key: 9328832 · Received November 15, 2019

    Report

    Report Number
    1818910-2019-114653
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    July 24, 2009
    Report Date
    October 25, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). 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. (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

    "LITERATURE ARTICLE ENTITLED, ¿IS THE SO-CALLED ¿FRENCH PARADOX¿ A REALITY?¿ BY F. EL MARI, ET AL, PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY (2010), VOL. 92-B, PP. 342-348, WAS REVIEWED. THE AUTHORS EVALUATED THE IN VIVO MIGRATION PATTERNS OF 164 PRIMARY CONSECUTIVE COMPETITOR TOTAL HIP REPLACEMENTS CEMENTED WITH DEPUY CDW-1 CEMENT WHICH WERE UNDERTAKEN IN 155 PATIENTS BETWEEN 1988-1989. DEPUY IMPLANTS USED: CDW-1 BONE CEMENT FOR A COMPETITOR CUP AND STEM. ALL OTHER COMPONENTS USED WERE COMPETITOR PRODUCTS. THE COMPETITOR CUP WAS POLYETHYLENE. RESULTS: 1 POSTOPERATIVE HEMATOMA TREATED WITH EVACUATION 16 HETEROTOPIC OSSIFICATION RADIOGRAPHICALLY IDENTIFIED. NO TREATMENT REQUIRED. ALL 8 ACETABULAR REVISION SURGERIES WERE RELATED TO WEAR OF THE POLYETHYLENE COMPETITOR CUP AND LOOSENING OF THE CUP DUE TO ACETABULAR OSTEOLYSIS ATTRIBUTED TO THE POLYETHYLENE WEAR. 7 STEMS REVISED DUE TO LOOSENING OF AN UNKNOWN INTERFACE. CAPTURED IN THIS COMPLAINT: CDW-1 CEMENT. THE COMPLICATIONS AND REVISIONS ATTRIBUTED TO THE COMPETITOR COMPONENTS ARE NOT INCLUDED IN THIS COMPLAINT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122147 UNKNOWN BONE CEMENT BONE CEMENT LOD DEPUY CMW - 9610921

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention