BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAC KNEE TIBIAL BEARING ARCOM UHMWPE

    MDR report key: 7384677 · Received March 30, 2018

    Report

    Report Number
    0001825034-2018-02260
    Event Type
    Injury
    Date Received
    March 30, 2018
    Report Date
    April 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF X-RAY REVIEW REPORT FROM MMI STATES THAT THERE IS INCREASED SPACING OF THE MEDIAL AND LATERAL COMPARTMENT, NONSPECIFIC, BUT CAN BE RELATED TO POSITIONING OR JOINT FLUID. THERE WAS NO SUGGESTION OF POLY WEAR RADIOGRAPHICALLY. FIT AND ALIGNMENT APPEAR WITHIN NORMAL LIMITS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE CANNOT BE DETERMINED FOR REPORTED ISSUE FOR REVISION DUE TO INSTABILITY AND WEAR. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RADIOGRAPHS REVIEWED INDICATED THAT THERE IS SMALL JOINT EFFUSION AND EVIDENCE OF POLYETHYLENE WEARING RADIOGRAPHICALLY. CONCOMITANT MEDICAL PRODUCTS: BMET ARCOM AP PATELLA 37MM, CATALOG #: 11-150824, LOT #: 741652; TRAC 65MM ANA PS FEM RT ILOK, CATALOG #: 150302 LOT #: 527140; TRAC 79MM TIBIAL PLATE, CATALOG #: 150139, LOT #: 758160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION FOR REASONS UNKNOWN AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE FUTURE REVISION PROCEDURE IS DUE TO THE PATIENT EXPERIENCING INSTABILITY AND POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229375 TRAC KNEE TIBIAL BEARING ARCOM UHMWPE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 812840

    Patients

    Seq Age Sex Outcome Treatment
    1 Other