BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC CDH POR N/C 7X114

    MDR report key: 8377950 · Received February 28, 2019

    Report

    Report Number
    0001825034-2019-00872
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    November 11, 2016
    Report Date
    March 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K921224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE EVENT, IT HAS BEEN DETERMINED THAT THIS EVENT WAS A RESULT OF A COINCIDING PROCEDURE, AND WILL BE REPORTED UNDER MEDWATCH 0001825034-2019-00863. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-173660 ¿ M2A MODULAR HEAD ¿ 430130; RD118856 ¿ M2A CUP ¿ 330980; 113845 - LOW PROFILE SCREW - 426960; 113846 - LOW PROFILE SCREW - 255104; 113847 - LOW PROFILE SCREW - 297849; 113845- LOW PROFILE SCREW - 454210. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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 - 2019 - 00873; 0001825034 - 2019 - 00875.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SECOND RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION. DURING THE SURGERY THE PATIENT EXPERIENCED ABOUT 1000ML OF BLOOD LOSS AND RECEIVED 225ML AUTOLOGOUS RED BLOOD CELLS FROM CELL SAVER REINFUSER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170963 BI-METRIC CDH POR N/C 7X114 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 966440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O