BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM 3 PEG/POST

    MDR report key: 7765548 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-07368
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    March 21, 2005
    Report Date
    September 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. 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). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEMORAL CATALOG # 183012 LOT # UNKNOWN; VANGUARD TIBIAL BEARING CATALOG # 183462 LOT # UNKNOWN; BIOMET CC I-BEAM TRAY CATALOG # 141226 LOT # UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-07365, 0001825034-2018-07366, 0001825034-2018-07367.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED. 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 FILLED FOR THIS EVENT: 0001825034-2018-07365-1; 0001825034-2018-07366-1; 0001825034-2018-07367-1.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT EXPERIENCED A FALL DURING PHYSICAL THERAPY. PATIENT HAS EXPERIENCED MULTIPLE FALLS PER DAY EVEN WITH WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606335 BIOMET ARCOM 3 PEG/POST JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R