BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN PLUS BONE CEMENT 20X2

    MDR report key: 19739513 · Received July 15, 2024

    Report

    Report Number
    3006946279-2024-00035
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    04040029110317
    PMA / PMN Number
    K150850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 155424, AGC TRAD UNIV INTLK FEM 70, LOT # 831565 11-150822, BMET ARCOM AP PATELLA 34MM, LOT #282770 158491, AGC V2 INTERLOK TIB 10X 71MM, LOT 770825 FOREIGN ¿ (B)(6). 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1-H4, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL EVALUATION COULD NOT BE PERFORMED. PRODUCT LEGACY TRANSFERRED TO BIOMET FRANCE IN 2010. DUE TO THE AGE OF THE PRODUCT, IT WAS NOT POSSIBLE TO RETRIEVE THE PRODUCT DHR. THEREFORE, A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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 A LEFT TOTAL KNEE ARTHROPLASTY WITH A FRACTURED MEDIAL TIBIAL COMPONENT. LUCENCY ALONG THE MEDIAL TIBIAL METAPHYSIS WITH ASSOCIATED BONY FRACTURE. CALCIFIED LOOSE BODY WITHIN THE SUPRAPATELLAR BURSA. SIGNIFICANT OSTEOPENIA IS NOTED ALONG THE PROXIMAL TIBIA WHICH COULD HAVE CONTRIBUTED TO THE FRACTURE. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED MORBID OBESITY AS CONTRIBUTING FACTOR TO THE EVENT. 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 HAD A LEFT TOTAL KNEE ARTHROPLASTY IMPLANTED ON AN UNKNOWN DATE NINETEEN YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED THREE MONTHS AGO DUE TO PAIN, INSTABILITY, AND DIFFICULTY AMBULATING. X-RAYS REVEALED FRACTURE OF THE TIBIAL IMPLANT WITH LOOSENING AND CONSIDERABLE BONE LOSS. DURING THE REVISION, THE PATELLA WAS FOUND IN THE SUPRAPATELLAR POUCH WITH LARGE PIECES OF CEMENT IN THE AREA AS WELL. THE FEMORAL COMPONENT WAS NOT LOOSE, BUT LARGE LYSIS MARGINS WERE NOTED. THE POLYETHYLENE INLAY WAS ALSO FOUND BROKEN ALONG WITH THE MEDIAL PART OF THE TIBIAL COMPONENT WHICH WAS GROSSLY LOOSE. ALL COMPONENTS WERE REMOVED WITHOUT COMPLICATION. THE TIBIAL AND FEMORAL COMPONENTS WERE REPLACED WITH UNKNOWN PRODUCT. THE PATELLA WAS FURTHER RESECTED WITHOUT A NEW REPLACEMENT. NO INTRAOP COMPLICATIONS WERE IDENTIFIED. 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
    268210 REFOBACIN PLUS BONE CEMENT 20X2 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A 98255127 04040029110317

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| H