BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD BIOMET TIBIAL AUGMENT

    MDR report key: 9403416 · Received December 3, 2019

    Report

    Report Number
    0001825034-2019-05447
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. JOINT ASSIST RECORDS REVIEW INDICATES THAT THE PATIENT WAS REVISED ON MAY 5, 2015 AND DURING THE IMPLANTATION OF ZIMMER BIOMET PRODUCTS, PROXIMAL TIBIA / DISTAL FEMUR NON-DISPLACED FRACTURES WERE NOTED AS INTRAOP COMPLICATIONS. OFFICIAL MEDICAL RECORDS WERE 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 0

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

    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: VANGUARD FEMORAL COMPONENT CATALOG # 185283 LOT # 3458069, TIBIAL COMPONENT CATALOG # 185203 LOT # 354030, VANGUARD DISTAL FEMUR AUGUMENT CATALOG # 185383 LOT # 761510, VANGUARD DISTAL FEMUR AUGUMENT CATALOG # 185403 LOT # 960320, VG 360 UNIV PST FM AUG CATALOG # 185343 LOT # 144500, VG 360 UNIV PST FM AUG CATALOG # 185343 LOT # 917410, BMT SPLINED KNEE STM CATALOG # 148316 LOT # 070820, BMT OFFSET ADAPTER CATALOG # 185210 LOT # 461680, BMT SPLINED KNEE STM CATALOG # 148318 LOT # 601210, BMT OFFSET ADAPTER CATALOG # 185210 LOT # 461680, VNGD SSK PSC TIB BRG CATALOG # 183890 LOT # 840400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-05404, 0001825034-2019-05405, 0001825034-2019-05439, 0001825034-2019-05440, 0001825034-2019-05441, 0001825034-2019-05442, 0001825034-2019-05443, 0001825034-2019-05444, 0001825034-2019-05445, 0001825034-2019-05446. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION KNEE ARTHROPLASTY DUE TO INFECTION. SUBSEQUENTLY, DURING THE REVISION PROCEDURE, THE PATIENT'S BONE DISPLAYED PROXIMAL TIBIA AND DISTAL FEMUR NON-DISPLACED FRACTURES. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195187 VANGUARD BIOMET TIBIAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 751480

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention