BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 67MM

    MDR report key: 7767278 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07337
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    March 17, 2008
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 60 CATALOG# 183004 LOT# UNK; VNGD CR LIP TIB BRG 12X63/67 CATALOG# 183522 LOT# UNK; UNKNOWN PATELLA. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 - 07338, 0001825034 - 2018 - 07336, 0001825034 - 2018 - 07334.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS NOTED PATIENT HAD A URINARY TRACT INFECTION APPROXIMATELY ONE MONTH POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607886 BIOMET CC I-BEAM TRAY 67MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R