BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 8209837 · Received January 2, 2019

    Report

    Report Number
    0001825034-2018-11563
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    July 18, 2018
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    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 · 0

    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, VNGD DIST FEM AUG 70X5 RL/LM CATALOG#: 184106 LOT#: 258290, VNGD DIST FEM AUG 70X5 LL/RM CATALOG#: 184126 LOT#: 115820, 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 · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: VANGUARD TI FEMORAL SSK, CATALOG #: CP113127, LOT #: 142810; BIOMET SPLINED KNEE STEM, CATALOG #: 148321, LOT #: 730560; VANGUARD FEMORAL DISTAL AUGMENT, CATALOG #: 184126, LOT #: 115820R; 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; VANGUARD FEMORAL DISTAL AUGMENT, CATALOG #: 184106, LOT #: 258290R. CUSTOMER HAS INDICATED PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11562 (PREVIOUSLY REPORTED ON IN 0001822565-2018-06318), 0001825034-2018-11563 (PREVIOUSLY REPORTED ON IN 0001822565-2018-06321). 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT REVISION PROCEDURE. SUBSEQUENTLY, PATIENT IS EXPERIENCING CONTINUED PAIN ATTRIBUTED TO LIMITED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244 VANGUARD PS TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 254570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention