BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH

    MDR report key: 19721054 · Received July 11, 2024

    Report

    Report Number
    0001822565-2024-02327
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K181947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. G2: FOREIGN: AUSTRALIA THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4, H4: IT WAS REPORTED THAT THE EXACT LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN AS IT IS UNKNOWN WHICH STEM WAS CONNECTED TO THE LOOSENED TIBIAL COMPONENT. THERE ARE TWO POTENTIAL DEVICES INVOLVED IN THE REPORTED EVENT: POTENTIAL LOT (1): 65635760. - MANUFACTURING DATE: NOV 7, 2022. - EXPIRATION DATE: NOV 4, 2032. - UDI: ((B)(4). POTENTIAL LOT (2): 65793242. - MANUFACTURING DATE: JAN 26, 2023. - EXPIRATION DATE: JAN 23, 2033. - UDI: ((B)(4). D10: MEDICAL PRODUCT: TIBIA FIXED CEMENTED RIGHT SIZE D STEM EXTENSION USE REQUIRED: CATALOG#42542006702, LOT#64753237; FEMUR CEMENTED STANDARD RIGHT SIZE 3: CATALOG#42504605402, LOT#64900831; ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 16 MM HEIGHT: CATALOG#42522400416; LOT#64798951. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TIBIAL IMPLANT LOOSENING OF THE RIGHT KNEE ARTHROPLASTY. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED RADIOGRAPHS. 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 TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL COMPONENTS. THE AFFECTED COMPONENTS WERE REPLACED WITHOUT COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271770 PERSONA STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. SEE H11 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization| R