BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD FEMORAL COMPONENT

    MDR report key: 18933841 · Received March 19, 2024

    Report

    Report Number
    0001825034-2024-00761
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    July 22, 2023
    Report Date
    May 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TATE, J. P., SCHNEIDER, A. M., BROWN, N. M. (2023) FEMORAL COMPONENT FRACTURE IN A TOTAL KNEE ARTHROPLASTY PATIENT WITH A PERSISTENT FLEXION CONTRACTURE. ARTHROPLASTY TODAY 22, ARTICLE 101174. HTTPS://DOI.ORG/10.1016/J.ARTD.2023.101174. D10 - CONCOMITANT DEVICES - UNKNOWN VANGUARD TIBIAL TRAY. UNKNOWN VANGUARD TIBIAL BEARING. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE DEVICE IS UNKNOWN. 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 REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11 H6: PROPOSED G CODE: MECHANICAL (G04) - FEMUR VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE FEMORAL IMPLANT IS FRACTURED. AS THE DEVICE WAS NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD BEEN FUNCTIONING WELL UNTIL PAIN DEVELOPED WITHOUT RECENT FALLS OR TRAUMA, PAIN 37/10, BEGAN AMBULATING WITH AN ALTERED GAIT AND A 30 DEGREE FLEXION CONTRACTURE; X-RAY SHOWED A FRACTURED FEMORAL COMPONENT AT THE ANTERIOR FLANGE; REVISION CONFIRMED THE ANTERIOR FLANGE FRACTURE BUT NO SIGNS OF OTHER DAMAGE, NO INDICATION OF CANTILEVERING MECHANISM OR OSTEOLYSIS A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS CONFIRMED FROM THE PROVIDED PICTURE. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND DIFFICULTY AMBULATING SECONDARY TO FEMORAL COMPONENT FRACTURE APPROXIMATELY TWELVE (12) YEARS POST-OPERATIVELY. DURING THE REVISION, THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT WAS WELL-FIXED, DESPITE BEING FRACTURED. NO OTHER DAMAGE WAS NOTED AND ONLY THE FEMORAL COMPONENT WAS REPLACED. THE PATIENT REPORTED NO COMPLICATION OR PAIN FOLLOWING THE REVISION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553914 UNKNOWN VANGUARD FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R SEE H10 NARRATIVE