BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAN PS CLSD INTLK FEM-RT 60

    MDR report key: 7768563 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07785
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    February 3, 2010
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VAN PS CLSD INTLK FEM-RT 60, PN 183204 LN UNKNOWN, VNGD PS TIB BRG 12X63/67MM, PN 183622 LN UNKNOWN, BIOMET CC I-BEAM TRAY 63MM, PN 141221 LN UNKNOWN, KNE-VANGUARD-PATELLAS-UNK, PN UNKNOWN LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-07785, 0001825034-2018-07786, 0001825034-2018-07787, 0001825034-2018-07789. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION 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 PATIENT WAS NOTED TO HAVE RIGHT KNEE PES BURSA INJECTION (GIVEN OR RECOMMENDED) APPROXIMATELY FOUR YEARS POST-IMPLANTATION. PATIENT WAS NOTED TO HAVE RADIOLUCENCIES ON THE RIGHT FEMORAL LATERAL VIEW: ZONE I AND ZONE II. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610634 VAN PS CLSD INTLK FEM-RT 60 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other