BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD ARCOM SERIES-A PATELLA

    MDR report key: 7505441 · Received May 10, 2018

    Report

    Report Number
    0001825034-2018-03284
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Report Date
    June 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK140902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    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

    CONCOMITANT MEDICAL PRODUCTS: 141236 BIOMET CC CRUCIATE TRAY 83MM J3937559, 183133 VAN PS OPEN INTL FEM-LT 72.5 757070, 183099 VANGUARD FEM PEGS SET 2 291520, EP-183661 E1 VNGD PS TIB BRG 79/83X11 981360, 42-422561 SIG TKA GDE/MDL SET 04-05 170200. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A PATELLA FRACTURE. IT IS UNKNOWN IF THE PATIENT WAS REVISED TO ADDRESS THE FRACTURED COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347496 VANGUARD ARCOM SERIES-A PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 578100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other