BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET KNEE SYSTEM PATELLA SINGLE ¼ INCH PEG

    MDR report key: 7303443 · Received February 28, 2018

    Report

    Report Number
    0001825034-2018-01583
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    September 1, 2017
    Report Date
    February 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 183014 J6053849 VANGUARD CR ILOK FEM-RT 75, 141226 J6073967 BIOMET CC I-BEAM TRAY 83MM, 189122 708470 VNGD ANT STBLZD BRG 12X83. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00609, 0001825034-2018-00586, 0001825034-2018-00672.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT KNEE PROCEDURE ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DEEP VEIN THROMBOSIS (DVT) 3 WEEKS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147739 BIOMET KNEE SYSTEM PATELLA SINGLE ¼ INCH PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 403820

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention