BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM TIBIAL BEARING

    MDR report key: 6900984 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07170
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 30, 2017
    Report Date
    October 26, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - UNKNOWN VANGUARD FEMORAL, UNKNOWN VANGUARD TIBIAL TRAY. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VG 360 UNIV PST FM AUG 75X5 CATALOG# 185348 LOT# 302420, VG 360 UNIV PST FM AUG 75X5 CATALOG# 185348 LOT# 371600, BMT 360 2.5 MM OFFSET ADAPTER CATALOG# 185210 LOT# 488090, BMT SPLINED KNEE STM 24X80 CATALOG# 141624 LOT# 992020, VNGD SSK 360 R FEM 75 MM CATALOG# 185268 LOT 3590889, BMT 360 TIB AUG 79 X 5 MM CATALOG# 185225 LOT # 331990, BMT 360 TIB TRAY 79 MM CATALOG# 185205 LOT 281070, BMT 360 TIB LG CRUCIATE WING CATALOG#185651 LOT#359790, BMT 360 7.5 MM OFFSET ADAPTER CATALOG#185212 LOT# 947110, BMT SPLINED KNEE STM 18X80 CATALOG# 141618 LOT 910320. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE DUE TO INSTABILITY APPROXIMATELY 1 YEAR POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681862 VANGUARD DCM TIBIAL BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 987330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R