BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT PS TIB BEARING 24X79/83

    MDR report key: 7836932 · Received August 31, 2018

    Report

    Report Number
    0001825034-2018-08657
    Event Type
    Injury
    Date Received
    August 31, 2018
    Report Date
    April 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK011219
    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 CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : UNKNOWN ASCENT FEMORAL CATALOG#: NI LOT#: NI, UNKNOWN ASCENT TIBIAL TRAY CATALOG#: NI LOT#: NI, BIOMET TIBIAL LOCKING BAR CATALOG#: 141205 LOT#: 042310. IT WAS PREVIOUSLY REPORTED THAT 0001825034-2018-08656 WAS ALSO SENT FOR THIS EVENT, BUT THAT PRODUCT WAS DETERMINED TO BE UNRELATED TO THIS ISSUE, AND WAS NOT REPORTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT'S SURGEON IS REQUESTING A THICKER TIBIAL BEARING TO COUNTERACT A KNEE DISLOCATION. IT IS UNKNOWN WHETHER A REVISION PROCEDURE HAS OCCURRED.

    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: UNKNOWN ASCENT FEMORAL CATALOG#: NI LOT#: NI, UNKNOWN ASCENT TIBIAL TRAY CATALOG#: NI LOT#: NI. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08656 AND 0001825034-2018-08657. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT'S SURGEON IS REQUESTING A THICKER TIBIAL BEARING TO COUNTERACT A KNEE DISLOCATION. A REVISION PROCEDURE HAS NOT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680735 ASCENT PS TIB BEARING 24X79/83 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 359800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention