BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MODULAR FEMORAL HEAD

    MDR report key: 7435682 · Received April 17, 2018

    Report

    Report Number
    3006946279-2018-00143
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 19, 2018
    Report Date
    February 27, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN, FRANCE. UDI - (B)(4). COMPLAINT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION; REVIEW OF THE PROVIDED PICTURES IDENTIFIED THAT THERE IS DISCOLORATION AND DEBRIS IN THE PACKAGING POUCH INSIDE THE STERILE PACKAGING TRAY. THE COMPLAINT HAS BEEN CONFIRMED BY VISUAL EVALUATION. DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO MANUFACTURING DEFICIENCY. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 INNER STERILE PACKAGING HAD DEBRIS AND DISCOLORATION BETWEEN THE PACKAGING AND THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278239 BIOMET MODULAR FEMORAL HEAD PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. N/A 0000738431

    Patients

    Seq Age Sex Outcome Treatment
    1