MAUDE Adverse Event Report: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number 60A4

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.We consider that the corticosteroid therapy was deeply involved with this event.Meanwhile, we cannot rule out the possibility that this event was caused by either other intraoperative factors or other factors related to postoperative management.Because the device (referenced in this report) was not returned to olympus terumo biomaterials corp.For evaluation, the causes of the adverse event have not been specified.The osferion bone void filler package insert states in the following section: adverse events: infection, fever, pain, local sensation, red flare, inflammation.This report is being submitted as a medical device report is an abundance of caution.

Event Description

A patient underwent high tibial osteotomy (hto).During the surgery, the surgeon in charge of the patient fixed the osteotomized tibia with a set of a metal plate and bone screws for internal fixation and implanted this product (bone void filler) into the bone defect formed after the osteotomy.After the surgery, however, the patient complained of a pain in the patient's affected lower limb.The surgeon observed that the affected lower limb gradually became swollen.The results of a pathological examination showed the evidence of (b)(6) infection.The patient, therefore, underwent a second surgery.In the second surgery, after removing the plate and bone screws and this product, the surgeon carried out wound irrigation and autologous bone grafting.Comments of the surgeon: the patient was being treated with 10ml of corticosteroid daily for cancer.The corticosteroid had possibly weakened the patient's immune system and made the patient vulnerable to infection.

• Brand Name: OSFERION
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 454-1 higashino,nagaizumi-cho; sunto-gun; shizuoka, 411-0 931; JA 411-0931
• Manufacturer (Section G): OLYMPUS TERUMO BIOMATERIALS CORP.; 1-50-1 sasazuka, shibuya-ku; tokyo, 151-0 073; JA 151-0073
• Manufacturer Contact: jiro hirai ; 1-50-1 sasazuka; shibuya-ku; tokyo, 151-0-073 ; JA 151-0073 ; 57383961
• MDR Report Key: 5482740
• MDR Text Key: 39744917
• Report Number: 3007738819-2016-00002
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 60A4
• Device Lot Number: M15618B677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR