BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 14X79/83

    MDR report key: 7768009 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07719
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    January 17, 2006
    Report Date
    August 9, 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-07717, 0001825034-2018-07720, 0001825034-2018-07721. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 75, ITEM# 183014, LOT# UNKNOWN. BIOMET CC I-BEAM TRAY 79MM, ITEM# 141225, LOT# UNKNOWN. UNKNOWN PATELLA, ITEM# UNKNOWN, LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT WAS NOTED TO HAVE UTI TREATED WITH LEVAQUIN. PATIENT EXPERIENCED A FALL AND BLISTERS NOTED ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610243 VNGD CR TIB BRG 14X79/83 PROSTHESIS- KNEE HRY ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention