BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CEMENT CMW

    MDR report key: 11052423 · Received December 21, 2020

    Report

    Report Number
    1818910-2020-27410
    Event Type
    Injury
    Date Received
    December 21, 2020
    Report Date
    December 6, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED.

    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.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED " ONE STAGE REVISION ARTHROPLASTY OF THE HIP FOR DEEP GRAM NEGATIVE INFECTION" WRITTEN BY V. V. RAUT, M. S. ORTH, M. CH. ORTH, P. D. SINEY, AND B. M. WROBLEWSKI PUBLISHED BY INTERNATIONAL ORTHOPAEDICS SPRINGER-VERLAG (1996) PAGES 20: 12-14. ACCEPTED BY PUBLISHER ON 06/07/1995 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO DESCRIBE THE USE OF ONE STAGE REVISION ARTHROPLASTY OF THE HIP FOR DEEP GRAM NEGATIVE INFECTIONS. DATA WAS COMPILED FROM FOLLOW-UP ON 15 PATIENTS FOR AN AVERAGE OF 8 YEARS. CEMENT MANUFACTURER FOR TWO OF THE PATIENTS REVISED WAS MANUFACTURED BY DEPUY, THE REMAINING 13 REVISED WERE OF COMPETITOR CEMENT. THE COMPONENTS IMPLANTED DURING THIS TRIAL WERE CHARNLEY INSTRUMENTS, BUT WERE IMPLANTED PRIOR TO 1991 AND NOT THE RESPONSIBILITY OF DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509242 UNK CEMENT CMW BONE CEMENT LOD DEPUY CMW - 9610921

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention