BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET E-POLY LINER

    MDR report key: 7351256 · Received March 19, 2018

    Report

    Report Number
    0001825034-2018-01842
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    December 22, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED, BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 11-363660, FEMORAL HEAD, LOT # 641190, ITEM # 12-104158, SHELL, LOT # 972760, ITEM # HIPS-UNKNOWN-STEMS-UNK, LOT # UNK. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH PHOTOGRAPHS RECEIVED. PHOTOGRAPHS OF THE EXPLANTED HEAD AND LINER WERE PROVIDED. THE LINER IS COMPLETELY WORN AND FRACTURED INTO MULTIPLE PIECES AND SCRATCHES WERE NOTED ON EXPLANTED COCR HEAD OUTER SURFACE. HOWEVER, NO FURTHER EVALUATION CAN BE PERFORMED BASED USING THE PHOTOGRAPHS PROVIDED AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED SINCE THE PRODUCT IS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO POLY LINER WEAR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192863 BIOMET E-POLY LINER HIP PROSTHESIS MAY ZIMMER BIOMET, INC. N/A 155640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R