BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL TRAY WITH LOCKING BAR & SCREW 75MM

    MDR report key: 7535940 · Received May 22, 2018

    Report

    Report Number
    0001825034-2018-03506
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 9, 2018
    Report Date
    January 3, 2019
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. MEDICAL DEVICE - UDI # - (B)(4). THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. REVISION OPERATIVE NOTES CONFIRM THAT THE LOCKING BAR BECAME LOOSE WITHOUT ANY TRAUMA. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 0

    (UDI) #: (B)(4). CONCOMITANT MEDICAL PRODUCTS - PALACOS BONE CEMENT CATALOG #: 00111314001 LOT #: 87434701, PALACOS BONE CEMENT CATALOG #: 00111314001 LOT #: 87424700 (QTY 3), PALACOS BONE CEMENT CATALOG #: 00111314001 LOT #: 87414698, BIOMET KNEE STEM 20MM X 80MM CATALOG #: 148170 LOT #: 315640, VANGUARD SSK 360 FEMORAL COMPONENT CATALOG #: 185266 LOT #: 3925361, 3 PEG PATELLA CATALOG #: 184764 LOT #: 381850, BIOMET 360 TIBIAL TRAY 75MM CATALOG #: 185204 LOT #: 038160, AUGMENT WING CATALOG #: 185650 LOT #: 370800, BIOMET KNEE STEM 16MM X 40MM CATALOG #: 148146 LOT #: 017790.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FIVE MONTHS POST-OPERATIVELY DUE TO PAIN AND THE LOCKING BAR BACKING OUT. INITIAL OPERATIVE NOTES IDENTIFIED NO COMPLICATIONS DURING THE PROCEDURE. REVISION OPERATIVE NOTES IDENTIFIED NO COMPLICATIONS DURING THE PROCEDURE. THE LOCKING CLIP AND POLYETHYLENE BEARING WERE REMOVED AND REPLACED, AND THE NEW COMPONENTS SHOWED EXCELLENT CATCHING OF THE POLYETHYLENE LOCKING MECHANISM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FIVE MONTHS POST-OPERATIVELY DUE TO PAIN AND THE LOCKING BAR BACKING OUT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376450 BIOMET 360 TIBIAL TRAY WITH LOCKING BAR & SCREW 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 038160

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R