BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X71/75

    MDR report key: 12780908 · Received November 9, 2021

    Report

    Report Number
    0001825034-2021-03089
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 26, 2021
    Report Date
    March 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304271135
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: THERAPY DATE: (B)(6) 2021; 167030 - VANGRD CR POR/HA FEM - RT 67.5 - 3775615; 141273 - BMET REGENX PRI TIB TRAY 71MM - 488230; 141310 - BIOMET I-BEAM PRI STEM 40MM - 136010. REPORT SOURCE: FOREIGN - (B)(6). THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY FIVE AND A HALF YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY FIVE YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681515 VNGD CR TIB BRG 10X71/75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 176850 00880304271135

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R