BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD CEMENTED PS OPEN BOX FEMORAL -RIGHT 67.5 MM

    MDR report key: 6543453 · Received May 4, 2017

    Report

    Report Number
    0001825034-2017-03037
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 5, 2017
    Report Date
    September 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THAT THE SHRINK WRAP APPEARS TO HAVE BEEN CUT OPEN ALONG THE EDGES OF THE FLAP CONSISTENT WITH BEING OPENED DURING USE. THE CARTON SHOWS SIGNS OF DAMAGE ON SIDES AND APPEARS TO HAVE BEEN RIPPED OPEN. ADDITIONALLY, IT WAS NOTED THAT THE CARTON APPEARS TO BE BULGING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. REVIEW WITH THE PACKAGING GROUP DETERMINED THAT THE MOST LIKELY ROOT CAUSE WAS THAT THE PACKAGING WAS DAMAGED DURING USE WHEN THE PRODUCT WAS BEING OPENED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATE: DEVICE AVAILABLE FOR EVAL APR 18, 2017. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CORRECT: LOT NUMBER - J3786159U, EXP. DATE ¿ FEB 13, 2027, MANUFACTURED ¿ FEB 13, 2017.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS RECEIVED, THE PACKAGING APPEARED TO HAVE EXPLODED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326787 VANGUARD CEMENTED PS OPEN BOX FEMORAL -RIGHT 67.5 MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS J3786159U

    Patients

    Seq Age Sex Outcome Treatment
    1