BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 65

    MDR report key: 7958104 · Received October 11, 2018

    Report

    Report Number
    0001825034-2018-09389
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    October 24, 2016
    Report Date
    March 25, 2019
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-09391. CONCOMITANT MEDICAL PRODUCTS: E1 VNGD CRL TIB BRG 71/75X10, ITEM# EP-183540, LOT# 383190; MODULAR PRESS FIT STEM 40MM, ITEM# 141350, LOT# 256040; BMET REGENX PRI TIB TRAY 75MM, ITEM# 141274, LOT# 279000; BMET ARCOM AP PAT 3PST 34MM MD, ITEM# 11-150842, LOT# 301610. CUSTOMER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL LEFT KNEE ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED DUE TO PAIN AND INSTABILITY APPROXIMATELY SEVEN YEARS POST IMPLANTATION. THE FEMORAL COMPONENT AND TIBIAL BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799469 VANGUARD CR ILOK FEM-LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 329280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R