BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET POLISHED FINNED TIB TRAY 83MM

    MDR report key: 22700637 · Received August 4, 2025

    Report

    Report Number
    0001825034-2025-02352
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    July 15, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    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: 183073 - VANGUARD CR POR FMRL-LT 72.5 -156090. 183460 - VNGD CR TIB BRG 10X79/83 - 156090. 184766 - SERIES A PAT STD 34 3 PEG - 362010. 3095040 - DEPUY GENTAMICIN BONE CEMENT - 2641200. 3095040 - DEPUY GENTAMICIN BONE CEMENT - 2641200. G2: FOREIGN COUNTRY: AUSTRALIA. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D4; G1; G3; G6; H1; H2; H3; H4; H6; H10. THE EVENT CANNOT BE CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PHOTOS IDENTIFIED EXPLANTED FEMORAL AND TIBIAL COMPONENTS COVERED IN BIO-DEBRIS. NO DEVICES WERE RETURNED AND NO FURTHER EVALUATIONS CAN BE MADE FROM THE PHOTOS PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. 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 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND WAS REVISED DUE TO BOTH FEMORAL AND TIBIAL LOOSENING AND INSTABILITY APPROXIMATELY 16 YEARS POST-OP. ALL COMPONENTS WERE REVISED. DURING SURGERY, CEMENT WAS FOUND IN THE POSTERIOR KNEE SPACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE 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
    205114 BIOMET POLISHED FINNED TIB TRAY 83MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 2008090247

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H SEE H11.