BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET FEMORAL HEAD

    MDR report key: 8030756 · Received November 1, 2018

    Report

    Report Number
    0001825034-2018-10187
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT IDENTIFICATION WAS RECEIVED THAT THE DEVICE IS MANUFACTURED BY THE ZIMMER BIOMET FRANCE SITE. A REPORT WILL BE SUBMITTED BY ZIMMER BIOMET FRANCE FOR THIS DEVICE AS IT IS RELATED TO THE EVENT.

    Description of Event or Problem · 0

    PRODUCT IDENTIFICATION WAS RECEIVED THAT THE DEVICE IS MANUFACTURED BY THE ZIMMER BIOMET FRANCE SITE. A REPORT WILL BE SUBMITTED BY ZIMMER BIOMET FRANCE FOR THIS DEVICE AS IT IS RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, HIP-UNKNOWN-CUPS-UNK, LOT # UNK; ITEM # UNK, HIP-UNKNOWN-LINERS-UNK, LOT # UNK; ITEM # UNK, HIP-UNKNOWN-STEMS-UNK, LOT # UNK. THE EVENT OCCURRED IN (B)(6). MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10187, 0001825034-2018-10189.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY ONE MONTH POST IMPLANTATION. THE PATIENT WAS REVISED TO A CONSTRAINED LINER AND CONSTRAINED FEMORAL HEAD. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867564 UNKNOWN BIOMET FEMORAL HEAD HIP PROSTHESIS KWZ ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R