BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BC R 1X40 US

    MDR report key: 18776002 · Received February 26, 2024

    Report

    Report Number
    3006946279-2024-00011
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    January 30, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    K171540
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CORRECTION: D2: MBB. CORRECTION: D10 - ASSOCIATED MEDICAL DEVICE TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G; ITEM#: 42-5320-079-02; LOT#: 64462320. VISUAL EXAMINATION OF PROVIDED PICTURES IDENTIFIED BOTH TIBIAL AND FEMORAL COMPONENTS. IT CAN BE NOTICED SOME CEMENT TRACES ON BOTH IMPLANTS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. THE BONE CEMENT WAS USED IN CONJUNCTION WITH THE REPORTED TIBIAL AND FEMORAL COMPONENTS; THIS COMBINATION HAS BEEN CONFIRMED TO BE APPROVED/CLEARED FOR USE AND IS A LEGALLY MARKETED COMBINATION. THIS COMBINATION WOULD NOT BE EXPECTED TO CONTRIBUTE TO THE REPORTED ISSUE. WITH THE AVAILABLE INFORMATION, 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 11; ITEM# 42-5026-070-02; LOT# 64522471. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F; ITEM# 42-5320-075-02; LOT# 64462320. ALL POLY PATELLA STANDARD CEMENTED SIZE 38 MM DIAMETER 9.5 MM THICKNESS; ITEM# 00-5972-065-38; LOT# 64488649. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT; ITEM# 42-5210-005-10; LOT# 64516250. 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.

    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 A RIGHT KNEE REVISION APPROXIMATELY THREE YEARS AND EIGHT MONTHS POST-IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. 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
    1909438 REFOBACIN BC R 1X40 US BONE CEMENT MBB BIOMET FRANCE S.A.R.L. 851DAH1704
    1985390 REFOBACIN BC R 1X40 US BONE CEMENT MBB BIOMET FRANCE S.A.R.L. 851DAH1704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.