BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD DIST FEM AUG 70X5 LL/RM

    MDR report key: 8962200 · Received September 4, 2019

    Report

    Report Number
    0001825034-2019-03846
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    July 18, 2018
    Report Date
    September 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11562, 0001825034-2018-11563, 0001825034-2019-03842, 0001825034-2019-03846. CONCOMITANT MEDICAL PRODUCTS: VNGD TI FEM SSK 70MM LT, CATALOG#: CP113127, LOT#: 142810, VANGUARD SSK PS TIBIAL BEARING, CATALOG #: 185082, LOT #: 254570, VNGD DIST FEM AUG 70X5 RL/LM CATALOG#: 184106 LOT#: 258290, BIOMET SPLINED KNEE STEM, CATALOG #: 148321, LOT #: 730560, BIOMET OFFSET TIBIAL TRAY ADAPTOR, CATALOG #: 141491, LOT #: 668350, BIOMET OFFSET TIBIAL TRAY WITH LOCKING BAR, CATALOG #: 141483, LOT #: 289850, BIOMET SPLINED KNEE STEM, CATALOG #: 148305, LOT #: 040880. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT KNEE REVISION PROCEDURE FOR ELEVATED METAL IONS LEVELS. SUBSEQUENTLY, THE PATIENT HAD TO UNDER GO MANIPULATION SIX (6) WEEKS POST OPERATIVE AS THE KNEE WAS NOT BENDING AS MUCH AS REQUIRED. THE PATIENTS STATES THAT THE KNEE WAS DAMAGED DURING MANIPULATION BY THE SURGEON. NOW AT TWELVE (12) WEEKS LATER THE PATIENT EXPERIENCES BRUISES, EXPERIENCING PAIN AND ATTRIBUTED TO LIMITED RANGE OF MOTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755542 VNGD DIST FEM AUG 70X5 LL/RM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 115820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention