BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BEARING

    MDR report key: 6396780 · Received March 10, 2017

    Report

    Report Number
    0001822565-2017-01660
    Event Type
    Injury
    Date Received
    March 10, 2017
    Report Date
    October 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK060525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034-2017-08084.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS VANGUARD RIGHT FEMUR 67.5MM CATALOG 183010 LOT 710940; SERIES A PATELLA CATALOG 184706 LOT 232620; COBALT BONE CEMENT CATALOG 402283 LOT 098100. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PATIENTS INITIALS ARE UNKNOWN, NOT (B)(6) AS PREVIOUSLY REPORTED. PRODUCT ID IS UNKNOWN, NOT PART 189660 , LOT 229040 , EXPIRATION DATE SEP 30, 2015 AS PREVIOUSLY REPORTED. IMPLANT DATE IS UNKNOWN, NOT (B)(6) 2010 AS PREVIOUSLY REPORTED. CONCOMITANT MEDICAL PRODUCT - UNKNOWN TIBIAL TRAY, UNKNOWN FEMORAL. THE 510K IS UNKNOWN, NOT K060525 AS PREVIOUSLY REPORTED. MANUFACTURE DATE IS UNKNOWN, NOT SEP 12, 2010 AS PREVIOUSLY REPORTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 BY THAT A PATIENT MAY BE UNDERGOING A REVISION OF THE TIBIAL BEARING DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT MAY UNDERGO A REVISION PROCEDURE DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176714 UNKNOWN BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 229040 

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention