BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 75MM

    MDR report key: 7759691 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06556
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    February 13, 2008
    Report Date
    October 1, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES FOUND. NO DEVICE FAILURE REPORTED. REPORTED ISSUE IS PROCEDURE RELATED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEMORAL COMPONENT CATALOGUE# 183010 LOT# UNKNOWN; VANGUARD BEARING CATALOGUE# 183444 LOT# UNKNOWN; BIOMET TIBIAL TRAY CATALOGUE# 141224 LOT# UNKNOWN; BIOMET PATELLA CATALOGUE# UNKNOWN LOT# UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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: 0001825034-2018-06554, 0001825034-2018-06555, 0001825034-2018-06556, 0001825034-2018-06557.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT WAS NOTED TO HAVE HOSPITALIZATION DUE TO PNEUMONIA AND BOWEL OBSTRUCTION EIGHT DAYS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599756 BIOMET CC I-BEAM TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R