BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR FINNED STEM

    MDR report key: 7432603 · Received April 16, 2018

    Report

    Report Number
    0001825034-2018-02332
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    April 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PRODUCT: REGENEREX SERIES-A PATELLA, CATALOG #: 141358, LOT #: 006220. VANGUARD TIBIAL BEARING, CATALOG #: EP-183542, LOT #: 755030. REGENEREX TIBIAL TRAY, CATALOG #: 141274, LOT #: 619090. VANGUARD FEMORAL COMPONENT, CATALOG #: 183048, LOT #: 374740. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06094, 0001825034-2017-06097, 0001825034-2017-06096, 0001825034-2017-06095.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY, SUBSEQUENTLY PATIENT IS EXPERIENCING PAIN WHEN CLIMBING STAIRS, PAIN FROM SITTING TO STANDING AND MINOR INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276647 BIOMET MODULAR FINNED STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 782730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other