BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 22848112 · Received August 20, 2025

    Report

    Report Number
    3002806535-2025-00370
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    September 1, 2024
    Report Date
    September 19, 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G2, G3, G6, H2, H6, H10, H11. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED, AND NO PICTURES WERE PROVIDED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DUE TO INSUFFICIENT PRODUCT INFORMATION, THE COMPATIBILITY OF THE INVOLVED PRODUCTS COULD NOT BE VERIFIED. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). 1.2 B: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. D10: UNKNOWN OXFORD TIBIAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. UNKNOWN OXFORD BEARING; ITEM NUMBER: UNKNOWN; LOT NUMBER: 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.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    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). DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED. THE STUDY REPORTED ONE PATIENT WITHIN THE MB GROUP WITH UNEXPLAINED PAIN RESULTING IN CONVERSION TO TOTAL KNEE ARTHROPLASTY (TKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244544 UNKNOWN OXFORD FEMORAL COMPONENT KNEE PROTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H