BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 22MM

    MDR report key: 22073638 · Received May 22, 2025

    Report

    Report Number
    0001825034-2025-01486
    Event Type
    Injury
    Date Received
    May 22, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: PANAMA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D5, G3, G6, H1, H2, H3, H6, H10, H11. D10: 150493 OSS REINFORCED YOKE LOT# 084840, 150478 OSS POLY LOCK PIN LOT# 890580, 150477 OSS POLY FEMORAL BUSHINGS LOT# 013750, 150367 OSS CEMENTED IM STEM 13X150 LOT# 157320, 150480 OSS AXLE LOT# 470890. VISUAL EXAMINATION OF THE PROVIDED IMAGES SHOWS THE FEMORAL AND THE BEARING COMPONENTS IMPLANTED IN THE PATIENT. NO PARTICULAR SIGNS OF DAMAGE CAN BE SEEN FROM THE PICTURES PROVIDED. NO FURTHER ASSESSMENT CAN BE MADE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLIANT 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 UNDERWENT A RIGHT KNEE REVISION SURGERY TWELVE YEARS POST IMPLANTATION DUE TO PERSISTENT PAIN, INFLAMMATION, AND FUNCTIONAL LIMITATION WERE OBSERVED. INTRAOPERATIVELY, IT WAS FOUND THAT THE POLYETHYLENE TIBIAL BEARING WAS SEVERELY WORN AND HAD RELEASED PARTICLES THAT TRIGGERED A CHRONIC INFLAMMATORY RESPONSE. THE SURGEON PERFORMED A SYNOVECTOMY AND LAVAGE, BUT NOTED THAT THE ONLY VIABLE SOLUTION MOVING FORWARD IS TO REPLACE THE TIBIAL BEARING. A FUTURE REVISION IS PLANNED.

    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
    1059508 OSS TIBIAL POLY BEARING 22MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. 028060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE