MAUDE Adverse Event Report: OSSUR H/F SYMBIONIC LEG 3

Model Number SMBE5260

Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

The patient reported to have fallen while walking the stairs due to the knee, and indicated the electronics sometimes stop working without any reason.The symbionic leg consists of a separate ankle unit and knee unit.Both units have been tested, including the electronics.In addition, the risks associated with the identified failure have been assessed.During the general quality check the leg did pass all the tests implying good functionality of the product.Both swing and resistance function of the knee were tested with good results.However, during the assessment of the ankle the error log showed that the electronic errors the user experienced during use indeed appeared: the ankle unit shuts off after giving a warning.This can be classified as an electronic failure.It was noted that an alarm alerted the user before it shuts off.The functionality of the knee is not suspected to be affected by the electronic failure of the ankle unit.Product failure has been identified, but the main expected cause of the fall is the loss of knee resistance, which is usually caused by user unintentionally triggering another state, for example swing mode instead of resistance mode.The ankle failure as described is unlikely to contribute to the fall as it will not directly affect the balance of the user and is unlikely to result in loss of knee resistance.In addition, an alarm is warning the user which lowers the chance on an incident.Based on findings as described above no further action is required.Issue was initially reported because a product malfunction was associated with the incident.After further analysis the actual malfunction is not suspected to be the root cause of the event and is not considered of high risk to the patient should it happen again.In addition, as this is the first complaint regarding this failure since the launch of the product, this is seen as a unique case.No further action is considered warranted.As a repair to the device electronics were replaced, sensors calibrated and the unit has been reset to factory settings.The product was tested and cleaned to be ready for use by the patient.(b)(6).Ossur is not aware of any similar events globally for this device.

Event Description

The patient reported to have fallen while walking the stairs due to the knee, and indicated the electronics sometimes stop working without any reason.He is not injured.

• Brand Name: SYMBIONIC LEG 3
• Type of Device: SYMBIONIC LEG 3
• Manufacturer (Section D): OSSUR H/F; reykjavik 110 ; IC 110
• MDR Report Key: 7975892
• MDR Text Key: 126221859
• Report Number: 3003764610-2018-00006
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SMBE5260
• Device Catalogue Number: SMBE5260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 83