BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT R 1X40 US

    MDR report key: 19457196 · Received June 4, 2024

    Report

    Report Number
    3006946279-2024-00027
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THAT OVERALL ALIGNMENT IS MAINTAINED. THERE IS FAINT OSTEOLYSIS ALONG THE TIBIAL IMPLANT WITH QUESTIONABLE SUBSIDENCE AND IMPLANT LOOSENING CANNOT BE EXCLUDED. BONE QUALITY IS OSTEOPENIC. THERE IS RADIOLUCENCY ALONG THE TIBIAL IMPLANT AS NOTED WITH QUESTIONABLE EARLY LOOSENING. OVERALL ALIGNMENT IS MAINTAINED. OTHER THAN THE ABNORMALITIES INVOLVING THE TIBIAL IMPLANT, NO OTHER FAILURE IS IDENTIFIED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED A CONVERSION OF PARTIAL KNEE TO TOTAL KNEE WITHOUT COMPLICATIONS. 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) D-10: 154720 OXF UNI TIB TRAY SZ B LM PMA, LOT # 941870, 161470, OXF TWIN-PEG CMNTD FEM LG PMA, LOT # 027380, 159556, OXF ANAT BRG LT LG SIZE 5 PMA, LOT # 863810. 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 WAS REVISED A MONTH AGO AFTER DEVELOPING ASEPTIC LEFT TIBIAL LOOSENING, FIVE YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609722 BIOMET BONE CEMENT R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. N/A 824EAC2202 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE