BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 9X150MM

    MDR report key: 8828242 · Received July 25, 2019

    Report

    Report Number
    0001825034-2019-03234
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    October 21, 2014
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A 38MM MOD HD -6MM NK, PN11-173660, LN000300; M2A 38MMX50MM CUP, PN RD118850, LN429070. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2016-01792, 0001825034-2016-01793.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 11 YEARS POST-IMPLANTATION DUE TO ELEVATED METAL ION LEVELS AND PAIN. DURING THE PROCEDURE, GRAY STAINED TISSUE, FLUID AND CYSTS WERE FOUND. ADDITIONALLY, STAINING ON THE TRUNNION OF THE STEM WAS ALSO NOTED. DURING THE PROCEDURE, THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A POLYETHYLENE ACETABULAR LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621537 MLRY-HD POR FMRL 9X150MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 250430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R