MAUDE Adverse Event Report: IWALK INC. BIOM T2; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXIT

Model Number BIOM T2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/01/2013

Event Type  Injury  

Event Description

User of the prosthesis (ankle/foot) reported that over a year earlier, he had fallen and broken the patella in his sound leg (the leg without the prosthesis).He reported that while pushing a heavy trash can, he stubbed the toe of the biom device which prompted it to provide power as it is designed to do on toe off, and that the powered push off put him off balance, resulting in a fall which drove his good knee into the ground, breaking the patella.User reported that the biom was not the cause of the fall leading to him breaking his patella per se, but that the power provided on the toe off contributed to him losing his balance and falling.No malfunction of the device was reported and the device has continued to function normally since the event.

Manufacturer Narrative

The user first informed an iwalk rep of the fall on (b)(6) 2013, but made no indication that treatment was required for the inquiry or that he felt the biom was at fault at that time, and referenced the fall only to explain why he had not corresponded in some time.A year later, on (b)(6) 2014, during another check-in with the user, he then indicated that he felt biom device was a contributing factor in the fall and resulting injury to his patella the previous year.There is no indication of a malfunction, and the user has continued to use the device since the incident.Since the user indicated that the device may have contributed to a fall leading to surgical intervention, this incident is considered a reportable event.

• Brand Name: BIOM T2
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXIT
• Manufacturer (Section D): IWALK INC.; bedford MA
• Manufacturer Contact: richard smith ; 4 crosby dr; bedford, MA 01730 ; 7817611570
• MDR Report Key: 4404544
• MDR Text Key: 18027996
• Report Number: 3008869754-2015-00001
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2014

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: Lay User/Patient
• Device Model Number: BIOM T2
• Device Catalogue Number: 11-00A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 97