BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 65

    MDR report key: 7758148 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05641
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    October 6, 2014
    Report Date
    August 22, 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-06360-1, 0001825034-2018-06366-1, 0001825034-2018-06376-1. CONCOMITANT MEDICAL PRODUCTS: VNGD ANT STBLZD BRG 10X75 ITEM# 189080 LOT# UNKNOWN, BIOMET CC I-BEAM TRAY 75MM ITEM# 141224 LOT# UNKNOWN, SERIES A PAT STD 31 3 PEG ITEM# 184764 LOT# UNKNOWN. 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: 0001825034-2018-06360; 0001825034-2018-06366; 0001825034-2018-06376. MEDICAL PRODUCTS: VNGD ANT STBLZD BRG 10X75 ITEM# 189080 LOT# UNKNOWN. BIOMET CC I-BEAM TRAY 75MM ITEM# 141224 LOT# UNKNOWN. SERIES A PAT STD 31 3 PEG ITEM# 184764 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 LEFT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT WAS NOTED TO HAVE PAIN AND SWELLING, DOPPLER (B)(6) . PATIENT WAS NOTED TO BE SENT TO ER FOR EVALUATION DUE TO RED STREAK GOING DOWN MID TIBIA AND INCREASED PAIN. NO SIGNIFICANT ISSUE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599457 VANGUARD CR ILOK FEM-LT 65 PROSTHESIS- KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other