BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM 67X10 MAX CR REMOVABLE POLY

    MDR report key: 20820419 · Received December 2, 2024

    Report

    Report Number
    0001825034-2024-02802
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 4, 2024
    Report Date
    February 25, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K984623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED FOREIGN MATERIAL ON THE SURFACE OF THE EXPLANT AS WELL AS WEAR AND DAMAGE TO THE DISTAL SURFACE. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL, AND IT WAS DETERMINED FURTHER REVIEW WOULD NOT ENHANCE THE INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED WITH THE PICTURE PROVIDED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE. TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 MEDICAL DEVICES: MAXIM POR ANA PRI FML 60 LT CATALOG#: 140071 LOT#: 851390. UNKNOWN TIBIAL TRAY CATALOG#: NI LOT#: NI. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY NINETEEN (19) YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105809 MAXIM 67X10 MAX CR REMOVABLE POLY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 530760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R