BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD KNEE SYSTEM PS+ TIBIAL BEARING E1 ANTIOXIDANT INFUSED

    MDR report key: 7785191 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-04355
    Event Type
    Injury
    Date Received
    August 15, 2018
    Report Date
    March 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE PROVIDED MEDICAL RECORDS WERE FOR THE LINKED COMPLAINT EVENT. NO MEDICAL RECORDS OR RADIOGRAPHS WERE RECEIVED FOR THE EVENT REPORTED ON THIS COMPLAINT. 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THE PATIENT IS STILL EXPERIENCING SWELLING OF THE KNEE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: ITEM # 184770 LOT # 079600. ITEM # 183214 LOT # 094410. ITEM # 141228 LOT # J2375563. KNE-OTHER-UNKNOWN-BEARING. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT HAS BEEN DISCARDED. 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: 0001825034-2018-04351, 0001825034-2018-04352, 0001825034-2018-04354.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY REVISION OF A BEARING. SUBSEQUENTLY PATIENT IS EXPERIENCING INSTABILITY. PATIENT IS BEING TESTED FOR METAL ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628660 VANGUARD KNEE SYSTEM PS+ TIBIAL BEARING E1 ANTIOXIDANT INFUSED PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 878990

    Patients

    Seq Age Sex Outcome Treatment
    1 Other