BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 22871754 · Received August 22, 2025

    Report

    Report Number
    3002806535-2025-00422
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    September 1, 2024
    Report Date
    September 3, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS BOTH THE ITEM AND LOT NUMBERS OF THE DEVICE ARE UNKNOWN. JOURNAL ARTICLE CITATION: FRICKA, K. B., WILSON, E. J., STRAIT, A. V., HO, H., HOPPER, JR, R. H., HAMILTON, W. G., & SERSHON, R. A., ET AL (2024). OUTCOMES OF FIXED VERSUS MOBILE-BEARING MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY. THE BONE & JOINT JOURNAL, 106-B NO.9, 916-923. HTTPS://DOI.ORG/10.1302/0301-620X.106B9.BJJ-2024-0075.R1. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL 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, G3, G6, H2, H3, H6, H10, H11. H11 - ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. BASED ON THE JOURNAL ARTICLE, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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

    ON 28-JUL-2025 A JOURNAL ARTICLE WAS RETRIEVED FROM THEN BONE & JOINT JOURNAL (2024) THAT REPORTED A STUDY FROM ALEXANDRIA, VIRGINIA, USA. THE PURPOSE OF THE STUDY WAS TO COMPARE OUTCOMES OF FIXED-BEARING (FB) AND MOBILE-BEARING (MB) UKAS FROM A SINGLE HIGH-VOLUME INSTITUTION. THE STUDY REVIEWED PRIMARY CEMENTED MEDIAL UKAS PERFORMED BY SEVEN SURGEONS FROM JANUARY 2006 TO DECEMBER 2022. A TOTAL OF 2,999 UKAS WERE IDENTIFIED, INCLUDING 2,315 FB AND 684 MB CASES. THE 684 CASES IN THE MB GROUP USED THE PHASE 3 OXFORD PARTIAL KNEE WITH TWO FEMORAL PEGS. THE STUDY POPULATION HAD A MEAN AGE AT SURGERY WAS 66.0 (32.9 TO 92.1), YEARS AT TIME OF SURGERY; (NUMBER OF 300MALES/384 FEMALES). MEAN LENGTH OF FOLLOW-UP 4.2 YEARS (3.6; 0.0 TO 15.6). THE STUDY REPORTED 1 PATIENT WITHIN THE MB GROUP WITH PATELLAR CREPITUS UNKNOWN TREATMENT OR TIMEFRAME.

    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
    2395286 UNKNOWN OXFORD TIBIAL COMPONENT KNEE PROSTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.