BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM TIBIAL BEARING 18MM X 79/83MM

    MDR report key: 6585286 · Received May 23, 2017

    Report

    Report Number
    0001825034-2017-03403
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    April 24, 2017
    Report Date
    August 11, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY REPORT REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). MEDICAL PRODUCT-VGD360 TIB LG CRUCIATE WING CATALOG# 185651 LOT# 957800, BMT 360 TIBIAL TRAY COCR 79MM CATALOG# 185205 LOT# 437540, BIOMET 360 5MM OFFSET ADAPTER CATALOG# 185211 LOT# 362200, VANG SSK 360/DA360 COCR FMRL RT 75MM CATALOG# 185268 LOT# 2556478, BMT SPLINED KNEE STM 120X18MM CATALOG# 141658 LOT# 642180, BMT SPLINED KNEE STM 16X80 CATALOG# 141616 LOT# 789920. (B)(6). 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 THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN APPROXIMATELY FOURTEEN MONTHS POST IMPLANTATION. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365743 VANGUARD DCM TIBIAL BEARING 18MM X 79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 553580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R