BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 65

    MDR report key: 18933812 · Received March 19, 2024

    Report

    Report Number
    0001825034-2024-00698
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 21, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270510
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2024-00699. D10-MEDICAL PRODUCT: VNGD ANT STBLZD BRG 20X75, ITEM# 189090, LOT# 072710. BMT SPLINED KNEE STM V2 13X160, ITEM# 148327, LOT# 600100. VG 360 DST FM AG 70X10 RL/LM, ITEM# 185386, LOT# 66059614. VG 360 DST FM AG 70X10 LL/RM, ITEM# 185406, LOT# 66044535. VG 360 UNIV PST FM AUG 70X5, ITEM# 185346, LOT# 66303815. VNGD SSK PSC TIB BRG 16X71/75, ITEM# 183886, LOT# 66280240. BIOMET TIBIAL LOCKING BAR, ITEM# 141205, LOT# 66177055. H3- 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR NO PHOTOGRAPHS WERE PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. X-RAY REVIEW BY MMI STATES THAT LEFT TOTAL KNEE ARTHROPLASTY WITH LARGE POLYETHYLENE LINER BUT OTHERWISE NO ABNORMALITY SEEN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS: - MECHANICAL (G04) - FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE YEARS AND NINE MONTHS POST IMPLANTATION DUE TO INSTABILITY. THERE IS NO ADDITIONAL INFORMATION 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
    2555811 VANGUARD CR ILOK FEM-LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6176789 00880304270510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| H| R| R SEE H10.