BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIMMER M/L TAPER PROSTHESIS FEMORAL STEM

    MDR report key: 6578825 · Received May 19, 2017

    Report

    Report Number
    0001822565-2017-03307
    Event Type
    Death
    Date Received
    May 19, 2017
    Date of Event
    December 31, 2015
    Report Date
    May 15, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK032726
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: VERSYS HIP SYSTEM FEMORAL HEAD, P/N 00801803202, L/N 61593580. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0002648920-2017-00304; 0001822565-2017-03307. REPORT# MW5068763.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE SIX YEARS POST-IMPLANTATION TO UNKNOWN REASONS. MECHANICALLY ASSISTED CREVICE CORROSION (MACC) OCCURS AT THE METAL/METAL MODULAR JUNCTION IN TOTAL HIP REPLACEMENTS AND CAN LEAD TO LOCAL TISSUE REACTION IN PATIENTS WITH METAL-ON-POLYETHYLENE TO TOTAL HIP REPLACEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358824 ZIMMER M/L TAPER PROSTHESIS FEMORAL STEM PROSTHESIS, HIP LZO ZIMMER, INC. N/A 60742959

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R