BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM SERIES-A STANDARD PATELLA

    MDR report key: 7065816 · Received November 28, 2017

    Report

    Report Number
    0001825034-2017-10563
    Event Type
    Injury
    Date Received
    November 28, 2017
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET CRUCIATE TIBIAL TRAY, CATALOG #: 141235 LOT #: J3710138. VANGUARD INTERLOK FEMORAL, CATALOG #: 183113 LOT #: 898870. VANGUARD TIBIAL BEARING, CATALOG #: EP-183662 LOT #: 691460. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10561, 0001825034-2017-10562, 0001825034-2017-10563, 0001825034-2017-10564 . REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERS FROM PAIN, A RASH, LOOSENING OF COMPONENTS, SENSITIVITY, SWELLING AND AN ELEVATED TEMPERATURE. PATIENT BELIEVES TO BE SUFFERING FROM AN ALLERGIC REACTION. UPON ADDITIONAL INFORMATION RECEIVED, IT HAS ALSO BEEN REPORTED THAT THE PATIENT RECEIVED THIRTY DAYS OF IV TREATMENT AFTER EXPERIENCING A REACTION TWO DAYS POST IMPLANTATION. HE STAYED IN THE HOSPITAL FOR TEN OF THOSE DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERS FROM PAIN, A RASH, LOOSENING OF COMPONENTS, SENSITIVITY, SWELLING AND AN ELEVATED TEMPERATURE. PATIENT BELIEVES TO BE SUFFERING FROM AN ALLERGIC REACTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844894 ARCOM SERIES-A STANDARD PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 304010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O