BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 VNGD AS TIB BRG 10X71

    MDR report key: 9470853 · Received December 15, 2019

    Report

    Report Number
    0001825034-2019-05470
    Event Type
    Malfunction
    Date Received
    December 15, 2019
    Report Date
    February 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (UDI): (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE PATIENT LACKS IN EXTENSION AND HAS PAIN, SWELLING AND STIFFNESS. PATIENT HAS HAD MULTIPLE FALLS. BONE SCAN CONFIRMS TIBIAL AND FEMORAL COMPONENTS ARE LOOSE. NEGATIVE FOR INFECTION. IT WAS CONFIRMED THAT THE TIBIAL AND FEMORAL COMPONENTS ARE LOOSE AND THAT THE PATIENT HAS LIMITED RANGE OF MOTION, SWELLING AND STIFFNESS; HOWEVER, WE ARE UNABLE TO CONFIRM PAIN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT BEGAN EXPERIENCING PAIN, SWELLING, STIFFNESS, DIFFICULTY AMBULATING, DECREASE IN ACTIVITIES OF DAILY LIVING, AND LOOSENING AFTER UNDERGOING AN INITIAL TKA APPROXIMATELY 2.5 YEARS AGO.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#:184702; SERIES A PAT W/WR STD 28 1 PEG LOT#: 824650, ITEM#:141233; BIOMET CC CRUCIATE TRAY 71MM; LOT#:J 6221493, ITEM#:183070; VANGUARD CR POR FMRL-LT 67.5 LOT#: 774600. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05469, 0001825034-2019-05471, 0001825034-2019-05472.

    Description of Event or Problem · 1

    PATIENT REPORTED HE UNDERWENT A LEFT TKA. SUBSEQUENTLY, PATIENT STATED HE BEGAN EXPERIENCING PAIN AND SORENESS APPROXIMATELY 1 AND 1/2 YEARS LATER. AFTER THERAPY, THE PAIN INCREASED ALONG WITH SWELLING AND STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265348 E1 VNGD AS TIB BRG 10X71 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 454400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other