BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 63MM

    MDR report key: 7753214 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-06080
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    June 29, 2007
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    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). THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO ITEM AND LOT IDENTIFICATION IS NECESSARY FOR REVIEW. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-06087, 0001825034-2018-06084, 0001825034-2018-06076.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY LEFT TOTAL KNEE ARTHROPLASTY SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE BILATERAL DEEP VEIN THROMBOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594325 BIOMET CC I-BEAM TRAY 63MM KNEE, PROTHESIS JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other