BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB BRG MED SZ4

    MDR report key: 18282944 · Received December 7, 2023

    Report

    Report Number
    3002806535-2023-00416
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 9, 2023
    Report Date
    February 20, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE NOT REVIEWED. ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. ALL PRODUCTS MANUFACTURED FOLLOW APPROPRIATE STANDARDS, AND THE REPORTED INFECTION OCCURRED ABOVE NINETY DAYS; THEREFORE, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: D4. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2-FOREIGN-AUSTRALIA D10. ITEM#: 154611;LOT#:856397 ;ITEM NAME: OXFORD UNI TIB TRAY 47X30 RLLM; ITEM#: 154601;LOT#:861147 ;ITEM NAME: OXFORD UNI FEMORAL MD; ITEM#: 6198B001;LOT#:ANTIBIOTIC SIMPLEX ;ITEM NAME: BLL058; INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. POLY EXCHANGE AND WASHOUT WERE PERFORMED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877643 OXFORD UNI TIB BRG MED SZ4 PROSTHESIS, KNEE NRA BIOMET UK LTD. 865238

    Patients

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