MAUDE Adverse Event Report: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

The device (referenced in this report) was not returned to olympus terumo biomaterials corp.For evaluation.The patient developed this adverse event eight years after the implantation of this product.Thus, we suppose that this product was not the immediate cause of this adverse event.This report is being submitted as a medical device report in an abundance of caution.

Event Description

During the operation: after curettage of the cystic lesion in the femoral head, the surgeon in charge of the patient implanted the "bone void filter (hereafter, this product)" into the resultant defect.Postoperative course: about 20 months after the surgery, it became clear that the treated femoral head had become necrosed (osteonecrosis of the femoral head).Thus, the surgeon determined to carry out reoperation.During the reoperation: the surgeon partially resected the femoral head, which was followed by hip resurfacing arthroplasty.During the reoperation, it was confirmed that the region into which this product had been implanted in the previous operation was mostly replaced with new bone.About six years after the reoperation: the patient has developed severe heterotopic ossification around the affected hip joint.Although the patient has not complained of pain, the range of motion of the affected hip joint is restricted.Surgeon's opinions: considering the properties of this product, we concluded that this product would hardly cause this type of adverse event, heterotopic ossification.We suppose that this adverse event attributes to other factors such as fine bone powder generated during surgery and hematomas.

• Brand Name: OSFERION
• Manufacturer (Section D): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 4541 higashino nagaizumicho; suntogun, shizuoka 411-0 931; JA 411-0931
• Manufacturer (Section G): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 4541 higashino nagaizumi-cho; suntogun, shizuoka 411-0 931; JA 411-0931
• Manufacturer Contact: jiro hirai ; 3-1 nishi-shinjuku 2-chome; shijuku-ku, tokyo 163-0-914 ; JA 163-0914 ; 69019264
• MDR Report Key: 4995790
• MDR Text Key: 22828225
• Report Number: 3007738819-2015-00009
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention