BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY TIBIAL BEARING 12MM X 63/67MM

    MDR report key: 16771134 · Received April 19, 2023

    Report

    Report Number
    0001825034-2023-00837
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 28, 2023
    Report Date
    August 16, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES: PRODUCT ID: BIOMET, PRODUCT TYPE: TIBIAL TRAY 67MM, CATALOG #: 141232, LOT #: J2886668, PRODUCT ID: MAXIM, PRODUCT TYPE: PRIMARY FEMORAL COMPONENT 60MM RIGHT, CATALOG #: 140011, LOT #: 813150, PRODUCT ID: SERIES A, PRODUCT TYPE: STANDARD PATELLA 34MM 3 PEG, CATALOG #: 184766, LOT #: 057130, DEPUY SMARTSET MV ENDURANCE BONE CEMENT CATALOG #: 3102080 LOT #: 3425476. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Additional Manufacturer Narrative · 0

    THE RETURNED ARTICULAR SURFACE SHOWED SIGNS OF USE AND WEAR DAMAGE WITH DELAMINATION AND DISCOLORATION. RADIOGRAPHS REVIEWED IDENTIFIED NONSPECIFIC SUBLUXATION OF THE TIBIA WITH RESPECT OF THE DISTAL FEMUR AND NARROWING OF THE LATERAL COMPARTMENT. ALTHOUGH THE POLYETHYLENE LINING WAS RADIOLUCENT AND SUBOPTIMALLY ASSESSED, THIS MAY BE A SECONDARY FINDING RELATED TO POLYETHYLENE WEAR. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION OF THE TIBIAL BEARING APPROXIMATELY TEN (10) YEARS POST-OPERATIVELY TO ADDRESS PAIN, INSTABILITY AND IMPLANT WEAR. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936405 MAXIM PRIMARY TIBIAL BEARING 12MM X 63/67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 194380

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H