BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 10X79/83MM

    MDR report key: 8898487 · Received August 15, 2019

    Report

    Report Number
    0001825034-2019-03599
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    October 2, 2018
    Report Date
    August 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- POLISHED FINNED TIB TRAY 83MM, CATALOG#: 141256, LOT NUMBER#: 2018010134, VNGD PS OPEN INTL FEM RT 70, CATALOG#: 183112, LOT#: J6183609. REPORT SOURCE: (B)(6). 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10763.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691234 VNGD PS TIB BRG 10X79/83MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 081220

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R