BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 70

    MDR report key: 8689855 · Received June 11, 2019

    Report

    Report Number
    0001825034-2019-02537
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    November 21, 2013
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT CANNOT BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN ZIMMER PATELLA. BMET REGENX PRI TIB TRAY 75MM, ITEM# 141274, LOT# 278890. BIOMET FINNED PRI STEM 40MM, ITEM# 141314, LOT# 896740. VNGD CR TIB BRG 10X71/75, ITEM# 183440, LOT# 560800. COBALT G-HV BONE CEMENT 40G, ITEM# 402283, LOT# 768500. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 A PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480683 VANGUARD CR ILOK FEM-RT 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 325910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R