BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB BRG MED SZ4

    MDR report key: 22016132 · Received May 14, 2025

    Report

    Report Number
    3002806535-2025-00189
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 9, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S LOT NUMBER IS UNKNOWN. D10: ITEM NUMBER: OXFORD UNI FEMORAL MD; ITEM NAME: 154601; LOT NUMBER: 1096294. ITEM NUMBER: OXF UNI TIB TRAY SZ B LM PMA; ITEM NAME: 154720; LOT NUMBER: 925333. G2 ¿ FOREIGN ¿ CANADA. 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

    (B)(4). D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S LOT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H6, H11. 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. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION SURGERY DUE TO A BEARING FRACTURE, APPROXIMATELY 19 YEARS, 2 MONTHS, AND 20 DAYS POST-IMPLANTATION. 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
    1748578 OXFORD UNI TIB BRG MED SZ4 KNEE PROSTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10 NARRATIVE