BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP INTERLOK TIBIAL TRAY 67MM

    MDR report key: 8491665 · Received April 8, 2019

    Report

    Report Number
    0001825034-2019-01616
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 15, 2019
    Report Date
    December 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PER THE IFU, 'MALALIGNMENT OR SOFT TISSUE IMBALANCE CAN PLACE INORDINATE FORCES ON THE COMPONENTS, WHICH MAY CAUSE EXCESSIVE WEAR TO THE PATELLAR OR TIBIAL BEARING ARTICULATING SURFACES. REVISION SURGERY MAY BE REQUIRED TO PREVENT COMPONENT FAILURE' AND 'IT IS THE RESPONSIBILITY OF THE OPERATING SURGEON TO DETERMINE WHETHER THERE IS ADEQUATE INITIAL FIXATION AND STABILITY,' THUS IT IS THE RESPONSIBILITY TO DETERMINE THE APPROPRIATELY SIZED COMPONENT TO USE. THEREFORE, THE ROOT CAUSE IS TRACED TO THE OPERATIONAL CONTEXT OF TIBIAL TRAY SELECTION BY THE SURGEON BASED ON THE INITIAL SIZING AT TIME OF IMPLANTATION. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES - VANGUARD INTERLOK FEMORAL COMPONENT LEFT 67.5MM; CATALOG #: 195923, LOT #: 179150; VANGUARD XP E1 MEDIAL TIBIAL BEARING 11MM X 63MM, CATALOG #: 195879, LOT #: 822960; VANGUARD XP E1 LATERAL TIBIAL BEARING 11MM X 63MM CATALOG #: 195809 LOT #: 658550. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL WILL NOT RETURN THE DEVICE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS THE TIBIAL COMPONENT, WHICH WAS UNDERSIZED. AT THE TIME OF THE REVISION, THE TIBIAL COMPONENT WAS ALSO NOT ANATOMICALLY ALIGNED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284922 VANGUARD XP INTERLOK TIBIAL TRAY 67MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 174950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R