BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 10X71/75MM

    MDR report key: 6949217 · Received October 13, 2017

    Report

    Report Number
    0001825034-2017-08683
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    October 16, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04242, 0001825034-2017-08683, 0001825034-2017-08677. CONCOMITANT MEDICAL PRODUCTS - BIOMET CC CRUCIATE TRAY 75MM CATALOG #: 141234 LOT #: J3465592, VAN PS OPEN INTL FEM-LT 72.5 CATALOG# 183133 LOT 899150, COBALT G-HV BONE CEMENT 40G CATALOG #: 402283 LOT #: 936990, AND COBALT HV BONE CEMENT 40G CATALOG #: 402282 LOT #: 457770. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND SWELLING TWO YEARS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728897 VNGD PS TIB BRG 10X71/75MM KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 604220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention