BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 19602560 · Received June 24, 2024

    Report

    Report Number
    3007738819-2024-00013
    Event Type
    Injury
    Date Received
    June 24, 2024
    Report Date
    June 25, 2024
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    PMA / PMN Number
    K080065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE CANNOT RULE OUT THE POSSIBILITY THAT THIS EVENT WAS CAUSED BY RELATED TO POSTOPERATIVE MANAGEMENT. WE CONCLUDED THAT THE QUALITY OF THIS PRODUCT HAS NO RELATIN TO THIS EVENT. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATUS IN THE FOLLOWING SECTION: <WARNING AND PRECAUTION> 1. IMPORTANT BASIC PRECAUTIONS (3) WHEN LOAD BEARING VAPACITY HAS BEEN WEAKENED OR REDUCED DUE TO FRACTURES, ETC., OS FERION SHOULD ONLY BE USED IF THE BONE CAN BE RELIABLY IMMOBLIZED BY USING EXTERNAL OR INTERNAL FIXATIONS ETC. OTHERWISE, COMPACTION OF FRACTURES MAY OCCUR. (4) IF NECESSARY, THE FRACTURE SHOULD BE STABILIZED USING EXTERNAL OR INTERNAL FIXATIONS TO PREVENT POST-IMPLANTATION MIGRATION OR EXTRUSION OF THE OSFERION DUE TO LOOSENING. <ADVERSE EVENTS> FRACTURE FEVER, PAIN, LOCAL SENSATION, RED FLARE, INFLAMMATION THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT OPENING WEDGE HIGH TIBIAL OSTEOTOMY WITH A DIAGNOSIS OF OSTEOARTHRITIS OF THE PATIENT'S RIGHT KNEE. THE SURGEON IN CHARGE OF THE PATIENT FIXED THE OSTEOTOMIZED BONE WITH A BONE PLATE AND BONE SCREWS AND FILLED THE SPACE CREATED AFTER THE OSTEOTOMY WITH ARTIFICIAL BONE (THIS PRODUCT). THE SURGEON PLACED THE BONE PLATE ON THE MEDIAL SURFACE OF THE TIBIA. AFTER THE SURGERY, THE FEMOROTIBIAL ANGLE (FTA) WAS CORRECTED FROM 180? TO 171? AND THE MEDIAL PROXIMAL TIBIAL ANGLE (MPTA) WAS CORRECTED FROM 84? TO 94?. NO REMARKABLE ADVERSE EVENTS WERE OBSERVED AFTER THE SURGERY. HOWEVER, X-RAY IMAGES TAKEN THREE MONTHS AFTER THE SURGERY REVEALED PLATE BREAKAGE AT A SCREW HOLE ABOVE THE OSTEOTOMY SITE WHICH IS USED TO INSERT A SCREW DIAGONALLY IN THE DIRECTION OF THE KNEE JOINT. THE LOWER LIMB ALIGNMENT ALSO CHANGED IN COMPARISON WITH THAT JUST AFTER THE SURGERY, WHICH WAS PROVED BY THE FTA VALUE OF 169? AND THE MPTA VALUE OF 97?. CT IMAGES TAKEN AT THAT TIME POINT DETECTED A TYPE 1' LATERAL HINGE FRACTURE, ALTHOUGH NO LATERAL HINGE FRACTURE HAD BEEN DETECTED IN A SERIES OF POSTOPERATIVE X-RAY IMAGES TAKEN DURING THREE MONTHS AFTER THE SURGERY. BEFORE LATERAL HINGE FRACTURE COMES TO BE EVALUATED BY USING CT SCAN, TYPE 1' LATERAL HINGE FRACTURE LIKE THAT IN THE PRESENT CASE HAS CONVENTIONALLY BEEN CLASSIFIED AS TYPE 1 LATERAL HINGE FRACTURE WITH X-RAY IMAGES. THE SURGEON CARRIED OUT REOPERATION AS FOLLOWS: REPLACING THE BROKEN BONE PLATE ON THE MEDIAL SURFACE OF THE TIBIA WITH A NEW BONE PLATE AND PLACING A DIFFERENT BONE PLATE ADDITIONALLY ON THE LATERAL SURFACE OF THE TIBIA. BOTH PLATES WERE FIXED WITH BONE SCREWS. THE SURGEON REMOVED ALL THE METAL IMPLANTS 18 MONTHS AFTER THE REOPERATION. AT PRESENT, THE FTA VALUE IS 171? AND THE MPTA VALUE IS 94?. WITHOUT COMPLAINING OF A KNEE PAIN, THE PATIENT IS ABLE TO SIT ON THE PATIENT'S HEELS. THE PATIENT IS MAKING FAVORABLE PROGRESS. COMMENTS FROM THE SURGEON: TYPE 1 LATERAL HINGE FRACTURE IS GENERALLY CONSIDERED STABLE. MEANWHILE, CONCERNING TYPE 1' LATERAL HINGE FRACTURE, THE LATERAL HINGE FRACTURE LINE REACHES THE TIBIOFIBULAR JOINT. TYPE 1' LATERAL HINGE FRACTURE HAS THEREFORE THE POTENTIAL OF BEING UNSTABLE AS IN THE CASE OF TYPE 3 LATERAL HINGE FRACTURE. REGARDING THE PATIENT IN THIS CASE, IT WAS DIFFICULT TO MAKE A DIAGNOSIS OF TYPE 1' LATERAL HINGE FRACTURE WITH POST-OPERATIVE X-RAY IMAGES. THIS CASE SHOWS THE SIGNIFICANCE OF TAKING CT IMAGES IN A CASE DEVELOPING A LATERAL HINGE FRACTURE IN ORDER TO CHECK WHETHER THE FRACTURE IS STABLE OR UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163821 OSFERION FILLER, BONE VOID, CALCIUM COMPOUND, PRODUCT CODE:MQV MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Hospitalization