BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTICULAR SURFACE

    MDR report key: 16522330 · Received March 10, 2023

    Report

    Report Number
    0001825034-2023-00490
    Event Type
    Injury
    Date Received
    March 10, 2023
    Report Date
    March 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN - UNKNOWN FEMORAL COMPONENT - UNKNOWN; UNKNOWN - UNKNOWN TIBIAL COMPONENT - UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: 0001825034-2023-00489.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE ARTICULAR SURFACE IS WORN. AS THE IMPLANTS WERE NOT RETURNED NO ADDITION EVALUATIONS WOULD BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL KNEE ARTHROPLASTY WITH LOOSENING OF THE ENTIRE TIBIAL COMPONENT AND POSSIBLE FRACTURE OF THE MEDIAL ASPECT OF THE TIBIAL COMPONENT. OVERALL FIT IS APPROPRIATE. POLYETHYLENE LINER NOT EVALUATED ON THIS STUDY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION ON AN UNKNOWN DATE. THERE WAS MENTION OF WEAR, METALLOSIS, AND POSSIBLE CEMENTING OF THE INITIAL IMPLANT. THE FEMUR WAS NOTED TO BE FIXED. THERE WAS METAL DEBRIS THROUGHOUT THE SYNOVIUM WITH A SUBSTANTIAL AMOUNT OF LYSIS IN THE MFC WITH BLACK TISSUE IN THE DEFECT. THE POLY WAS NOTED TO BE WORN. THE TIBIA COMPONENT APPEARS TO BE FRACTURED IN PROVIDED PHOTOGRAPHS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1231192 UNKNOWN ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H SEE H10.