MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-04 for SYMBIONIC LEG SMBL3240 manufactured by Ossur.
[18086682]
Patient (b)(6) was in her backyard and went to take a step with her prosthetic side and the knee bent as she stepped but it did not swing back out. Patient fell and suffered a hip fracture. She has not used the symbionic leg since she fell, but has been in and out of the office and is recovering just fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00002 |
| MDR Report Key | 4527415 |
| Report Source | 05 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-02-04 |
| Date Mfgr Received | 2014-12-29 |
| Date Added to Maude | 2015-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIONIC LEG |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT |
| Product Code | ISW |
| Date Received | 2015-02-04 |
| Returned To Mfg | 2014-01-13 |
| Model Number | SMBL3240 |
| Catalog Number | SMBL3240 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-04 |