BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 75

    MDR report key: 8160229 · Received December 13, 2018

    Report

    Report Number
    0001825034-2018-11265
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: E1 VNGD CRL TIB BRG 79/83X10; P/N: EP-183560, L/N: 507810. VANGUARD CR ILOK FEM-LT 75; P/N: 183034, L/N: 557460. BIOMET CC CRUCIATE TRAY 83MM; P/N: 141236, L/N: J2476424. SERIES A PAT STD 40 3 PEG; P/N: 184770, L/N: 211620. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11264, 0001825034-2018-11266, 0001825034-2018-11281. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY 7 YEARS POST IMPLANTATION. THE PATIENT HAS EXPERIENCED PAIN SINCE THEN. SUBSEQUENTLY, THE PATIENT'S PAIN HAS INCREASED SINCE HEARING A SNAPPING NOISE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001924 VANGUARD CR ILOK FEM-LT 75 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 557460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other