BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS OPEN INTL FEM RT 70

    MDR report key: 8078344 · Received November 16, 2018

    Report

    Report Number
    0001822565-2018-06501
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    August 31, 2018
    Report Date
    August 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE INITIAL MDR WAS SUBMITTED ON INCORRECT MFR. THE REPORT WILL BE SUBMITTED ON 0001825034-2019-03719.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE INITIAL MDR WAS SUBMITTED ON INCORRECT MFR. THE REPORT WILL BE SUBMITTED ON 0001825034-2019-03719.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN, (B)(6). CONCOMITANT MEDICAL PRODUCTS: PN: 141256, LN: 2018010134, POLISHED FINNED TIB TRAY 83MM. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT DEBRIDEMENT TO TREAT DELAYED WOUND HEALING POST INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921016 VNGD PS OPEN INTL FEM RT 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6183609

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R