BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAN PS OPEN INTL FEM

    MDR report key: 7762770 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-05287
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    November 5, 2014
    Report Date
    July 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    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: BIOMET CC I-BEAM TRAY 91MM CATALOG # 141228 LOT # UNKNOWN, SERIES A PAT STD 40 3 PEG CATALOG # 184770 LOT # UNKNOWN, VNGD PS+ TIB BRG 14X87/91MM CATALOG # 183784 LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT 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. 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 - 05292 REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION DUE TO UNKNOWN REASON

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604705 VAN PS OPEN INTL FEM KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention