BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH STEM

    MDR report key: 6866704 · Received September 14, 2017

    Report

    Report Number
    0001825034-2017-07116
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 23, 2017
    Report Date
    January 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCT: VANGUARD 360 FEMORAL, CAT#: 185266 LOT#: 3702874. BIOMET SMOOTH STEM, CAT#: 145026 LOT#: 045450. VANGUARD 360 TIBIAL TRAY, CAT#: 161432 LOT#: 2857200. UNKNOWN VANGUARD BEARING, CAT#: UNKNOWN LOT#: UNKNOWN. UNKNOWN PALACOS CEMENT, CAT#: UNKNOWN LOT#: UNKNOWN. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2017-07113. 0001825034-2017-07114. 0001825034-2017-07115. 0001825034-2017-07116. 0001825034-2017-07117. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT INCORRECT FEMORAL COMPONENT IMPLANTED INTO THE PATIENT CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, THIS PRODUCT IS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644016 BIOMET SMOOTH STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 470020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R