BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD POSTERIOR OPEN INTL FEMORAL - LEFT

    MDR report key: 9617507 · Received January 22, 2020

    Report

    Report Number
    0001825034-2020-00334
    Event Type
    Injury
    Date Received
    January 22, 2020
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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: VNGD PS TIB BRG 14X71/75MM CATALOG # 183644 LOT # 231070, BIOMET CC CRUCIATE TRAY 75MM CATALOG # 141234 LOT # 267800, SERIES A PAT STD 31 3 PEG CATALOG # 184764 LOT # 380260, STBLECUT HYPERBLADE AO/SD .054 CATALOG # 907238 LOT # 506104, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 849960, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 590590, OPTIVAC KIT 80GRAM DOUBLE MIX CATALOG # 417200 LOT # 1904362, 1/8 QUICK REL DRL STERILE 2PK CATALOG # 32-486265 LOT # 368110. 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: 0001825034-2020-00335, 0001825034-2020-00336, 0001825034-2020-00337. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WILL BE CONSIDERED FOR REVISION DUE TO PAIN. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81835 VANGUARD POSTERIOR OPEN INTL FEMORAL - LEFT PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 490110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other