BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN TIBIAL TRAY

    MDR report key: 8925770 · Received August 23, 2019

    Report

    Report Number
    0001822565-2019-03601
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    November 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE THE COMPLAINT DESCRIPTION AND PATIENT CODES.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. MEDICAL RECORDS WERE NOT PROVIDED AND PRODUCT WAS NOT RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A REVISION SURGERY, THE PATIENT DEVELOPED A SEVERE INFECTION AND WAS HOSPITALIZED FOR FIVE WEEKS. HE HAD FOLLOW UP APPOINTMENTS DAILY AT THE HOSPITAL CLINIC FOR AN ADDITIONAL FOUR WEEKS. IT TOOK THREE MONTHS FROM THE REVISION SURGERY FOR HIM TO WALK WITHOUT AID. HIS RIGHT LEG IS SWOLLEN AND IT IS PAINFUL AND UNCOMFORTABLE TO WALK PROLONGED DISTANCES. HE IS NOT FULLY MOBILE AND IS NOT ABLE TO FULLY FLEX HIS KNEE. THE PATIENT HAS A LIMP AND, IF HE TWISTS OR LEANS TO ONE SIDE, HE TENDS TO FALL OVER. HE HAS DIFFICULTY SLEEPING DUE TO LOW GRADE PAIN DISCOMFORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2019-03599. 0001822565-2019-03600. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN BEARING. UNKNOWN NEXGEN FEMORAL. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A REVISION PROCEDURE A PATIENT DEVELOPED AN INFECTION AND IT IS ALLEGED THAT HIS KNEE IS VERY SWOLLEN AND HE CANNOT WALK ANY PROLONGED DISTANCES. HIS KNEE ALSO CONTINUES TO BE PAINFUL. HE IS NOT ABLE TO FLEX HIS KNEE AND HAS A LIMP. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719379 UNKNOWN NEXGEN TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other