BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL PLATE

    MDR report key: 9265592 · Received November 1, 2019

    Report

    Report Number
    0001825034-2019-04887
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    May 8, 2018
    Report Date
    February 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. MEDICAL RECORDS REVIEW INDICATES THAT AT THREE YEARS PATIENT WAS EXPERIENCING PAIN AND OFTEN FELLS GRINDING AND HEARS CLICKING. VERY STIFF AND DIFFICULTY WITH FUNCTIONAL ABILITIES. 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). (B)(6). MEDICAL PRODUCTS: VANGUARD (TM) DCM TIBIAL BEARING CATALOG # 189120 LOT # 674660, VANGUARD (TM) CR FEMORAL CATALOG # 183054 LOT # 709350, BIOMET SERIES A STANDARD PATELLA CATALOG # 184768 LOT # 996200, BIOMET MODULAR FINNED STEM CATALOG # 141314 LOT # 951910, COBALT HV WITH GENTAMICIN BONE CEMENT CATALOG # 402283 LOT # 674550. 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: 0001825034-2019-04894, 0001825034-2019-04904, 0001825034-2019-04905. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PAIN, NOISE, STIFFNESS, DECREASE IN ADLS AND OVERALL DECREASE IN SATISFACTION AT THREE YEAR FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060117 BIOMET TIBIAL PLATE PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 085820

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other