BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT 2X40G

    MDR report key: 8788896 · Received July 15, 2019

    Report

    Report Number
    3006946279-2019-00321
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 19, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    PMA / PMN Number
    K150850
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT BE RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE REPORTED EVENT COULDN'T BE RECREATED AS THE PRODUCT WAS NOT RETURNED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT BIOMET BONE CEMENT 2X40G REFERENCE (B)(4), LOT NUMBER A605DA1904 WERE MANUFACTURED ON 25 JULY 2016 ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE EVENT DESCRIBED IN THE COMPLAINT. 6 COMPLAINTS HAVE BEEN RECORDED FOR BIOMET BONE CEMENT 2X40 G, REFERENCE (B)(4), LOT NUMBER A605DA1904 WITHIN ONE YEAR. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. ACCORDING TO AVAILABLE DATA, THE MOST PROBABLE ROOT CAUSE IS DUE TO PACKAGING ISSUE (SEALING PROCESS). CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. 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

    IT HAS BEEN REPORTED THAT THE INNER PACKAGE LEAKED. THE EVENT WAS DETECTED BEFORE THE SURGERY STARTED, THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENTS HAVE BEEN REPORTED AS RÉSULTAT OF THE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) # : (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT BIOMET BONE CEMENT 2X40G REFERENCE: 3035890022, LOT NUMBER A605DA1904 WERE MANUFACTURED ON 25 JULY 2016 ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE EVENT DESCRIBED IN THE COMPLAINT. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THEREFORE IT WILL NOT BE ANALYZED. ACCORDING TO AVAILABLE DATA, THE MOST PROBABLE ROOT CAUSE IS DUE TO PACKAGING ISSUE (SEALING PROCESS). CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. 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 PACKAGE LEAKED. THE EVENT WAS DETECTED BEFORE THE SURGERY STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584865 BIOMET BONE CEMENT 2X40G BONE CEMENT LOD BIOMET FRANCE S.A.R.L. A605DA1904

    Patients

    Seq Age Sex Outcome Treatment
    1