BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT 55MM RIGHT

    MDR report key: 14493065 · Received May 24, 2022

    Report

    Report Number
    0001825034-2022-01262
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 30, 2022
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VANGUARD CRUCIATE RETAINING TIBIAL BEARING 12MM X 59MM CATALOG #: 183402 LOT #: 165990, SERIES A STANDARD 3 PEG PATELLA 28MM CATALOG #: 184762 LOT #: 874050, VANGUARD BIOMET TIBIAL TRAY 59MM CATALOG #: 141220 LOT #: 557170. THE COMPLAINANT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2022-01261. INVESTIGATION INCOMPLETE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR RADIOGRAPHS PROVIDED WERE REVIEWED AND DEMONSTRATED ANTERIOR DISLOCATION OF THE TIBIA WITH RESPECT TO THE FEMUR. NO OTHER ABNORMALITIES WERE IDENTIFIED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS DISLOCATION OF THE FEMORAL COMPONENT ON TIBIAL ARTICULATION APPROXIMATELY ELEVEN (11) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194682 VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT 55MM RIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 312020

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R