BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 KNEE SYSTEM OFFSET ADAPTOR WITH SCREWS

    MDR report key: 8970239 · Received September 6, 2019

    Report

    Report Number
    0001825034-2019-03978
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 5, 2019
    Report Date
    January 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. IMAGES SHOW DISASSOCIATION OF THE TIBIAL STEM FROM THE TIBIA OFFSET ADAPTER. LUCENCY SURROUNDING THE TIBIAL STEM SUGGEST POSSIBLE LOOSENING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BMT 360 TIB 5.0 OFFSET ADAPTER; P/N: 185211, L/N: 770850; BMT SPLINED KNEE STM V2 13X80; P/N: 148303, L/N: 877150; BMT SPLINED KNEE STM V2 17X120; P/N: 148320, L/N: 739090; BMT 360 TIB AUG 63X5MM; P/N: 185221, L/N: 690760; BMT 360 TIB SM CRUCIATE WING; P/N: 185650, L/N: 101390; BMT 360 TIB TRAY 63MM; P/N: 185201, L/N: 543210; VNGD SSK PSC TIB BRG 18X63/67; P/N: 183868, L/N: 436870; VNGD SSK 360 L FEM 60MM; P/N: 185282, L/N: 3852858. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03979, 0001825034 - 2019 - 03980. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO KNEE FAILED INTO VARUS. SUBSEQUENTLY, THE TIBIAL STEM DISASSOCIATED FROM THE OFFSET ADAPTER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762362 BIOMET 360 KNEE SYSTEM OFFSET ADAPTOR WITH SCREWS PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 770850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R