BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 7514540 · Received May 15, 2018

    Report

    Report Number
    0001825034-2018-03310
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 16, 2018
    Report Date
    February 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED BY A REVIEW OF THE INOPERATIVE PHOTOS WHICH CLEARLY DEMONSTRATES THE LOCKING BAR IN THE SOFT TISSUE OF THE KNEE. IT CAN BE IMPLIED THAT THIS IS THE SOURCE OF THE PATIENT'S PAIN. THE PATIENT'S POLY BEARING AND LOCKING BAR HAVE BEEN REPLACED. INSPECTION OF THE RETURNED DEVICE SHOWED WEAR. THE BEARING COMPONENT ALSO SHOWED WEAR MARKS ON THE SURFACE OF THE DEVICE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ANALYSIS OF THE LOCKING BAR DETERMINED THAT THE LOCKING BAR CONTACT MARK & DEFORMATION OBSERVATIONS ARE CONSISTENT WITH THE BAR NOT BEING FULLY ENGAGED WITH THE TIBIAL TRAY. HOWEVER, IT CANNOT BE CONFIRMED WITH CERTAINTY WHETHER THE REPORTED LOCKING BAR DISSOCIATION OCCURRED DUE TO IMPROPER INSERTION. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY THE CORRECTED INFORMATION. THE CORRECTION MADE DOES NOT CHANGE ANY INVESTIGATION RESULTS. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS. CONCOMITANT MEDICAL PRODUCTS: 185108, PS TIBIAL BEARING, 934200, VANGUARD FEMORAL AUGMENT 185348 LOT 718040, VANGUARD FEMORAL 185288 LOT 3833410, VANGUARD POSTERIOR FEMORAL AUGMENT 185428 LOT 613230, BIOMET TIBIAL TRAY 185205 LOT 127270, VANGUARD DISTAL FEMORAL AUGMENT 185388 LOT 921890, BIOMET STEM 145026 LOT 772760, BIOMET STEM 145026 LOT 118460, TIBIAL CRUCIATE WING 185651 LOT 079420, 92-2010, CALCIGEN 3, 625150, 348014, CALCIGEN S BONE GRAFT SYSTEM, 834560. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 PRESENTED WITH PAIN POST LEFT KNEE ARTHROPLASTY AND AFTER X-RAYS WERE TAKEN THE LOCKING BAR WAS FOUND TO HAVE BACKED OUT INTO THE PATIENT'S SOFT TISSUE. PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR MONTHS POST IMPLANTATION; THE LOCKING BAR AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358250 BIOMET TIBIAL LOCKING BAR PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 944480

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R