BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN PLUS BONE CEMENT 40

    MDR report key: 20123403 · Received September 3, 2024

    Report

    Report Number
    3006946279-2024-00055
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    07350023774437
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT POLISHED FINNED TIB TRAY 75MM ITEM# 141254 LOT # 2014071637 VANGUARD CR FEM 72.5 RT-MACH ITEM# 183013-01 LOT# 760550 SERIES A PAT W/WR STD 31 1 PEG ITEM# 184704 LOT# 651580 VNGD CR LIP TIB BRG 14X71/75MM ITEM# 183544 LOT# 357300. G2- AUSTRALIA. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. THE FOLLOWING SECTION WAS CORRECTED: D4. 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. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THAT TIBIAL IMPLANT IS LOOSE AS NOTED. FEMORAL IMPLANT FIT IS MAINTAINED. THERE IS VARUS MALALIGNMENT OF THE KNEE SECONDARY TO THE TIBIAL IMPLANT MEDIAL SUBSIDENCE. BONE QUALITY IS OSTEOPENIC. THERE IS ABNORMAL RADIOLUCENCY ALONG THE TIBIAL IMPLANT WITH LOOSENING. THERE IS RESULTING VARUS MALALIGNMENT. THE TIBIAL IMPLANT LOOSENING AND RESULTING MALALIGNMENT WOULD LEAD TO REVISION. NO OTHER ABNORMALITIES ARE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. 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 A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE YEARS AND FIVE MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT WITH VARUS COLLAPSE. ALL INITIAL COMPONENTS WERE REMOVED. NO FURTHER ATTEMPTS WERE MADE AS ALL REQUIRED INFORMATION IS AVAILABLE.

    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
    701056 REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A414AF2405 07350023774437

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.