BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH KNEE STEMS 16X40

    MDR report key: 7562307 · Received June 1, 2018

    Report

    Report Number
    0001825034-2018-03757
    Event Type
    Injury
    Date Received
    June 1, 2018
    Report Date
    March 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATE/CORRECTED REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 185264, VNGD SSK 360 R FEM 65MM, 6082525; 185211, BMT 360 TIB 5.0 OFFSET ADAPTER, 881810; 185651, BMT 360 TIB LG CRUCIATE WING, 700880; 185084, VNGD SSK PS TIB BRG 14X71/75, 299930; 185210, BMT 360 2.5MM OFFSET ADAPTER, 550180; 185203 BMT 360 TIBIAL TRAY 71MM 392640. 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: 0001825034-2018-03680; 0001825034-2018-03681; 0001825034-2018-03757; 0001825034-2018-03758; 0001825034-2018-03759; 0001825034-2018-03760; 0001825034-2018-03761. 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 THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE AND SUBSEQUENTLY IS NOW EXPERIENCING PAIN, SWELLING, SENSITIVITY, AND MAY BE HAVING A POSSIBLE ALLERGIC REACTION TO THE IMPLANTS. IT IS FURTHER REPORTED THAT THE PATIENT HAS STABBING PAIN IN THE GROWN AREA TO MID SHIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405636 BIOMET SMOOTH KNEE STEMS 16X40 KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 693670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other