BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR INTERLOK FEM

    MDR report key: 8185587 · Received December 20, 2018

    Report

    Report Number
    0001825034-2018-11457
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    October 20, 2012
    Report Date
    April 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11456 - 1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD CR TIB BRG; P/N: EP-183440, L/N: 269830, VANGUARD CR INTERLOK FEM; P/N: 183013, L/N: 558550, POLISHED FINNED TIB TRAY; P/N: 141253, L/N: 2010101707, SERIES A PAT; P/N: 184786, L/N: 8750. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS AND 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 - 11456, 0001825034 - 2018 - 11457. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY SIX YEARS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT EXPERIENCED STIFFNESS AND LIMITED RANGE OF MOTION THAT WAS RESOLVED POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024333 VANGUARD CR INTERLOK FEM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 558550

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention