BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIB BRG 71/75 X 10 MM

    MDR report key: 13025967 · Received December 17, 2021

    Report

    Report Number
    0001825034-2021-03367
    Event Type
    Injury
    Date Received
    December 17, 2021
    Report Date
    December 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL EXAMINATION OF THE PICTURES PROVIDED WITHIN THE MEDICAL RECORDS FOUND BLACK TISSUE WAS REMOVED FROM THE KNEE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED OF THE DEVICES; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND KNEE PAIN 15 DAY¿S POST OP. X-RAY REVIEW FOUND IMPLANTS WERE IN GOOD POSITION. NO DVT. FURTHER MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. ADDITIONAL ASSOCIATED PRODUCTS AND MDRS: 183108 VAN PS OPEN INTL FEM-RT 65 65 LOT# 196810 MDR: 0001825034-2021-03365; 141234 BIOMET CC CRUCIATE TRAY 75MM MM LOT# J2905890 MDR: 0001825034-2021-03366.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAD PHYSICAL THERAPY FOR RIGHT TOTAL KNEE RECONSTRUCTION 8 YEARS, 4 MONTHS POST PROCEDURE FOR 2 MONTHS. PATIENT WAS REVISED ON AN UNKNOWN DATE AND UNKNOWN REASON. 'PATIENT STATES ON PICTURES, THIS IS WHAT WAS REMOVED FROM MY KNEE.' NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927093 VANGUARD PS TIB BRG 71/75 X 10 MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 808960

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H