BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BC R 1X40 US

    MDR report key: 16403323 · Received February 20, 2023

    Report

    Report Number
    3006946279-2023-00018
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    January 8, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    00880304990197
    PMA / PMN Number
    K171540
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NAME:VNGD ANT STBLZD BRG 14X79, ITEM NUMBER:189104, LOT NUMBER:321720. ITEM NAME:VANGUARD CR ILOK FEM-RT 70, ITEM NUMBER:141215, LOT NUMBER:J7181424. ITEM NAME:SERIES A PAT STD 34 3 PEG, ITEM NUMBER: 184766, LOT NUMBER:152410. ITEM NAME:UNK TIBIAL STEM EXT, ITEM NUMBER:UNK TIBIAL STEM EXT, LOT NUMBER:240000. ITEM NAME:REFOBACIN BC R 1X40 US, ITEM NUMBER:110034355, LOT NUMBER:AY25CI2901. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PRODUCT WAS NOT RETURNED OR PICTURES NOT PROVIDED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE REVIEW OF THE STERILIZATION CERTIFICATE INDICATES THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATION. THIS DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE REVIEWED. 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. TISSUE CULTURE RESULTED POSITIVE FOR MSRA (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS) IN (B)(6) 2023. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. A DEFINITIVE ROOT CAUSE CANNOT 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 APPROXIMATELY FOUR MONTHS AFTER TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1407090 REFOBACIN BC R 1X40 US BONE CEMENT MBB BIOMET FRANCE S.A.R.L. N/A Y46BAJ2103 00880304990197

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H