MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for SYMBIONIC LEG 3 SMBE5260 manufactured by Ossur H/f.
[126221859]
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.
Patient Sequence No: 1, Text Type: N, H10
[126221860]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2018-00006 |
| MDR Report Key | 7975892 |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYMBIONIC LEG 3 |
| Generic Name | SYMBIONIC LEG 3 |
| Product Code | ISW |
| Date Received | 2018-10-17 |
| Model Number | SMBE5260 |
| Catalog Number | SMBE5260 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | REYKJAVIK 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-17 |