BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 12X79/83

    MDR report key: 8424657 · Received March 15, 2019

    Report

    Report Number
    0001825034-2019-01246
    Event Type
    Injury
    Date Received
    March 15, 2019
    Date of Event
    February 18, 2019
    Report Date
    August 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATING, IT WAS DISCOVERED THAT AN INCORRECT DATE WAS SUBMITTED FOR THE INITIAL PROCEDURE. THE INITIAL SURGERY OCCURRED ON AN UNKNOWN DATE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. A PHOTOGRAPH OF THE EXPLANTED DEVICE WAS PROVIDED AND SHOWS SOME BLOOD STAINS ON THE DEVICE. PRODUCT WAS NOT RETURNED THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELEVANT 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.

    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: VANGUARD CR POR FEM-RT 70, ITEM# 183052, LOT# 322710; BIOMET POR PRI TIB TRAY 79MM, ITEM# 141265, LOT# 442310; BIOMET FINNED PRI STEM 40MM, ITEM# 141314, LOT# 522910. REPORT SOURCE- (B)(6). 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 AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY WAS REVISED DUE TO INSTABILITY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217867 VNGD CR TIB BRG 12X79/83 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 230570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R