BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR CUP

    MDR report key: 6969039 · Received October 23, 2017

    Report

    Report Number
    0001822565-2017-07399
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    August 23, 2017
    Report Date
    November 16, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE-LITERATURE: DIESEL, C. V., RIBEIRO, T. A., GUIMARÃES, M. R., DE SOUZA MACEDO, C. A., & GALIA, C. R. (2017). ACETABULAR REVISION IN TOTAL HIP ARTHROPLASTY WITH TANTALUM AUGMENTATION AND LYOPHILIZED BOVINE XENOGRAFT. REVISTA BRASILEIRA DE ORTOPEDIA (ENGLISH EDITION), 52, 46-51. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE REPORTED 1 ISOLATED RELEASE OF THE ACETABULAR COMPONENT THAT REQUIRED FURTHER SURGERY. THE STUDY REPORTED THE TANTALUM WEDGE REMAINED FIXATED AT ITS ORIGINAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747865 UNKNOWN ACETABULAR CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R