BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNE-UNKNOWN-TIBIAL

    MDR report key: 10884650 · Received November 23, 2020

    Report

    Report Number
    0001825034-2020-04165
    Event Type
    Injury
    Date Received
    November 23, 2020
    Report Date
    December 18, 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
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED, AS PATIENT CONFIRMED THEY WERE IMPLANTED WITH COMPETITOR DEVICES, NOT ZIMMER BIOMET PRODUCT.

    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: ASSOCIATED PRODUCTS : ITEM#:UNKNOWN; KNE-UNKNOWN-FEMORAL; LOT#:UNKNOWN. 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: 0001825034-2020-04164.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY TWO AND HALF YEARS AGO. SUBSEQUENTLY, PATIENT HAS LIMITED RANGE OF MOTION, PAIN AND SWELLING. PATIENT HAS UNDERWENT ALLERGY TESTING AND IS ALLERGIC TO NICKEL AND NEEDS THE MATERIAL COMPOSITION OF THE DEVICES IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353459 KNE-UNKNOWN-TIBIAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other