BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMET ARCOM AP PAT 3PST 37MM LG

    MDR report key: 7916664 · Received September 27, 2018

    Report

    Report Number
    0001825034-2018-09218
    Event Type
    Injury
    Date Received
    September 27, 2018
    Report Date
    September 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    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). CONCOMITANT MEDICAL PRODUCTS: VNGD PS TIB BRG, CATALOG # 183464, LOT # UNKNOWN; VANGUARD CR ILOK FEM-LT, CATALOG # 183034, LOT # UNKNOWN; BIOMET ARCOM 3 PEG/POST, CATALOG # UNKNOWN, LOT # UNKNOWN; BIOMET CC I-BEAM TRAY, CATALOG #: 141226, LOT #: 317670; BIOMET ARCOM PATELLA, CATALOG #: 11-150844, LOT #: 799300. 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: 0001825034-2018-07892; 0001825034-2018-07924; 0001825034-2018-07928; 0001825034-2018-09217. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE INTRA-ARTICULAR INJECTION DUE TO PAIN AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754647 BMET ARCOM AP PAT 3PST 37MM LG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 799300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R