BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL CRUCIATE WING

    MDR report key: 6895873 · Received September 26, 2017

    Report

    Report Number
    0001825034-2017-07392
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    December 1, 2015
    Report Date
    November 21, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN ADDITIONAL ITEM AND MEDWATCH WERE ADDED FOR THIS EVENT: MEDWATCH# 0001825034-2017-10446. CONCOMITANT PRODUCTS: VANGUARD TIBIAL BEARING CAT#: 185110 LOT#624650. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET SSK 360 FEMORAL, CAT#: 185267, LOT#: 3458058. BIOMET 360 TIBIAL TRAY, CAT#: 185205 LOT#: 543990. BIOMET 360 OFFSET ADAPTER, CAT#: 185210 LOT#: 314950. BIOMET 360 TIBIAL OFFSET ADAPTER, CAT#: 185211 LOT#: 970140. BIOMET SPLINED KNEE STEM, CAT#: 141620 LOT#: 481350. BIOMET SPLINED KNEE V2 STEM, CAT#: 148295 LOT#: 631690. VANGUARD DISTAL FEMORAL AUGMENT, CAT#: 185387 LOT#: 002200. VANGUARD DISTAL FEMORAL AUGMENT, CAT#: 185407 LOT#: 304400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07374, 0001825034-2017-07375, 0001825034-2017-07386, 0001825034-2017-07387, 0001825034-2017-07388, 0001825034-2017-07389, 0001825034-2017-07390, 0001825034-2017-07391.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT WAS SCHEDULED TO BE REVISED DUE TO PAIN. IT WAS NOTED THAT THE PATIENT HAD CANCELLED THE OPERATION AND WAS DISCHARGED DUE TO FAILURE TO COMPLY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO BE REVISED FOR UNKNOWN REASONS. IT WAS NOTED THAT THE PATIENT HAD CANCELLED THE OPERATION AND WAS DISCHARGED DUE TO FAILURE TO COMPLY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673720 BIOMET 360 TIBIAL CRUCIATE WING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 727980

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention