BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS OPEN INTL FEM RT 70

    MDR report key: 8078366 · Received November 16, 2018

    Report

    Report Number
    0001825034-2018-10763
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 2, 2018
    Report Date
    August 15, 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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REPORTED ISSUES ARE RELATED TO THE PROCEDURE AND ARE NOT ABNORMAL TO THE PROCEDURE. NO FAILURE DETECTED WITH THE DEVICES. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY AND SUFFERED DELAYED WOUND HEALING APPROXIMATELY TWO (2) MONTHS AFTER POST INITIAL SURGERY AND UNDERWENT WOUND DEBRIDEMENT. SUBSEQUENTLY THE PATIENT EXPERIENCE DELAYED WOUND HEALING TWO (2) MONTHS POST WOUND DEBRIDEMENT AND AGAIN UNDERWENT A WOUND DEBRIDEMENT PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). (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 SUFFERED DELAYED WOUND HEALING APPROXIMATELY 2 MONTHS AFTER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916762 VNGD PS OPEN INTL FEM RT 70 KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. N/A J6183609

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R