BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM

    MDR report key: 18912733 · Received March 15, 2024

    Report

    Report Number
    3007963827-2024-00075
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    February 21, 2024
    Report Date
    June 19, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024469464
    PMA / PMN Number
    K150090
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2:AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. AN ADEQUATE COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS THE FAILURE MODE EXPERIENCED BY THE USER IS UNKNOWN. MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLAINT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 THE PATIENT FELL & RUPTURED PCL. IT WAS NOT THE OPINION OF THE HCP OR PATIENT THAT THE FALL WAS RELATED TO THE IMPLANTS. THE POLY WAS EXCHANGED WITH AN INCREASED THICKNESS & UC FOR STABILITY. MC TO UC AND THICKER POLY TO MAKE UP FOR PCL DEFICIT AND IMPROVED STABILITY.

    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
    966236 PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64403822 00889024469464

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R