BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM SERIES A STANDARD PATELLA

    MDR report key: 7767073 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07495
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    May 23, 2007
    Report Date
    August 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    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). MEDICAL PRODUCT: VANGUARD CR ILOK FEMORAL, CATALOG #: 183014, LOT #: UNK. VANGUARD STABILIZED BEARING, CATALOG #: 183584, LOT #: UNK. BIOMET I-BEAM TRAY, CATALOG #: 141227, LOT #: UNK. BIOMET ARCOM 3 PEG/POST PATELLA, CATALOG #: UNK, LOT #: UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: 0001822565-2018-07492; 0001822565-2018-07493; 0001822565-2018-07494; 0001822565-2018-07495. 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT WAS NOTED TO HAVE BLOOD IN URINE REQUIRING VISIT TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609890 ARCOM SERIES A STANDARD PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention