BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PATELLA

    MDR report key: 19512715 · Received June 11, 2024

    Report

    Report Number
    0001825034-2024-01546
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 21, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K040770
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: E1 VNGD PS TIB BRG 63/67X10 CATALOG # EP-183620 LOT # 181130. UNK VANGUARD TIBIAL COMPONENT CATALOG # UNK LOT # UNK. UNK VANGUARD FEMORAL COMPONENT CATALOG # UNK LOT # UNK. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. 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. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. VISUAL EVALUATION OF THE PHOTOGRAPH PROVIDED SHOWS THAT THE DEVICE HAS WEAR CONSISTENT WITH USAGE. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. X-RAY REVIEW INDICATES THERE IS RADIOLUCENCY SURROUNDING THE MAJORITY OF THE PATELLAR IMPLANT, GREATEST LATERALLY, WHICH APPEARS LOOSE. THERE IS NO EVIDENCE OF FEMORAL OR TIBIAL IMPLANT LOOSENING AND OVERALL, KNEE ALIGNMENT IS ANATOMIC. BONE QUALITY IS OSTEOPENIC. 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 PATIENT UNDERWENT A REVISION PROCEDURE ELEVEN YEARS POST IMPLANTATION FOR PAIN DUE TO PATELLAR LOOSENING. NO MORE INFORMATION IS 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
    814954 VANGUARD PATELLA PROSTHESIS KNEE HRY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE.