BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS+ TIB BRG 10X71/75MM

    MDR report key: 7758056 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06016
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    June 10, 2014
    Report Date
    September 18, 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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-06013. MEDICAL PRODUCTS: VNGD PS OPEN INTL FEM RT 75 ITEM# 183114 LOT# UNKNOWN , BIOMET CC I-BEAM TRAY 75MM ITEM# 141224 LOT# UNKNOWN, SERIES A PAT STD 34 3 PEG ITEM# 184766 LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT UNDERWENT MANIPULATION. PATIENT WAS NOTED TO HAVE PAIN, REDNESS AND SWELLING REQUIRING VISIT TO THE ER. PATIENT WAS FOUND TO BE NEGATIVE FOR DEEP VEIN THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596731 VNGD PS+ TIB BRG 10X71/75MM PROSTHESIS- KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention