BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL DISTAL AUGMENT 5MM X 60MM

    MDR report key: 7929308 · Received October 3, 2018

    Report

    Report Number
    0001825034-2018-09304
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    July 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT 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). CONCOMITANT MEDICAL PRODUCTS: VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 18MM X 71/75MM, CATALOG #: 185048, LOT #: 765060, VANGUARD SSK FEMORAL COMPONENT ¿ RIGHT 60MM, CATALOG #: 183302, LOT #: 993190, VANGUARD POSTERIOR FEMORAL AUGMENT 5MM X 60MM, CATALOG #: 184142, LOT #: 357200, BIOMET SPLINED STEM WITH SCREW, CATALOG #: 141618, LOT #: 220740, BIOMET MODULAR TIBIAL LOCKING BAR, CATALOG #: 141205, LOT #: 533370, BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE 71MM, CATALOG #: 141233, LOT #: J2409086, BIOMET ALL POLY PATELLA BUTTON 34MM DIAMETER, CATALOG #: 11-150842, LOT #: 067390. IT IS INDICATED BY THE COMPLAINANT THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2018-09299; 0001825034-2018-09303; 0001825034-2018-09305; 0001825034-2018-09306; 0001825034-2018-09307; 0001825034-2018-09308; 0001825034-2018-09309.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING, LIMITED RANGE OF MOTION, CRACKING NOISES, A PULLING FEELING AT THE BACK OF THE LEG, A SUNKEN AREA AT THE TOP OF HER KNEE AND A LARGE KNOT INSIDE THE KNEE FOLLOWING RIGHT KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771846 VANGUARD FEMORAL DISTAL AUGMENT 5MM X 60MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 755510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other