BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 22892677 · Received August 26, 2025

    Report

    Report Number
    3002806535-2025-00425
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    May 26, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. D10 - ASSOCIATED MEDICAL DEVICES: UNKNOWN OXFORD TIBIAL COMPONENT; ITEM# UNKNOWN; LOT# UNKNOWN. UNKNOWN OXFORD BEARING; ITEM# UNKNOWN; LOT# UNKNOWN. UNKNOWN CEMENT; ITEM# UNKNOWN; LOT# UNKNOWN. G2 - FOREIGN: GERMANY. JOURNAL ARTICLE CITATION: KOCH, K.A., THAPA, M, WEISHORN, J., HARIRI, M., LOTZ, M., KNAPPE, K., REINER, T., WALKER, T. (2025). CEMENTED MOBILE-BEARING MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY PROVIDES LONG-TERM IMPLANT SURVIVAL AND SUSTAINED FUNCTIONAL PERFORMANCE IN YOUNG AND ACTIVE PATIENTS AGED 60 OR BELOW. KNEE SURG SPORTS TRAUMATOL ARTHROSC 1¿9. DOI: 10.1002/KSA.12703. 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 MEDWATCH 3500A 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. 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 WILEY ¿ KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY (2025) THAT REPORTED A STUDY FROM HEIDELBERG, GERMANY. THE PURPOSE OF THE STUDY WAS TO EVALUATE LONG-TERM OUTCOMES OF CEMENTED, MOBILE-BEARING MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) IN PATIENTS AGED 60 OR YOUNGER. THE RETROSPECTIVE SINGLE-CENTER STUDY INCLUDED 119 KNEES (102 PATIENTS). ALL PROCEDURES USED THE MOBILE-BEARING OXFORD PARTIAL KNEE IMPLANT WITH A MINIMALLY INVASIVE, CEMENTED APPROACH BY 12 SURGEONS. THE INDICATION FOR SURGERY WAS ADVANCED OSTEOARTHRITIS OF THE MEDIAL COMPARTMENT (116 KNEES) OR AVASCULAR NECROSIS OF THE MEDIAL FEMORAL CONDYLE (THREE KNEES), WITH INTACT ACL AND COLLATERAL LIGAMENTS. THE STUDY POPULATION HAD A MEAN AGE OF =60 YEARS AT THE TIME OF SURGERY. CLINICAL AND RADIOGRAPHIC FOLLOW-UP EXAMINATIONS WERE RECOMMENDED AT REGULAR INTERVALS AFTER 3 MONTHS, 1 YEAR, 3 YEARS, 5 YEARS AND EVERY 5 YEARS THEREAFTER FOLLOWING THE INDEX SURGERY, AVERAGE FOLLOW-UP PERIOD OF 16 YEARS. THE STUDY REPORTED ONE PATIENT, 62 YEARS OF AGE, WITH WEAR RESULTING IN REVISION TO TKA 10 YEARS POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    2723389 UNKNOWN OXFORD FEMORAL COMPONENT KNEE PROSTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Hospitalization| R