MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-06 for SYMBIONIC LEG SMBL2240 manufactured by Ossur.
[5443304]
Prosthetic patient was walking using a symbionic leg and fell which resulted in a broken hip.
Patient Sequence No: 1, Text Type: D, B5
[12837049]
Patient subsequently passed away from pneumonia.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2015-00004 |
| MDR Report Key | 4516630 |
| Report Source | 05 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-02-05 |
| Date Mfgr Received | 2015-01-28 |
| Date Added to Maude | 2015-02-18 |
| 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 | 2015-02-06 |
| Model Number | SMBL2240 |
| Catalog Number | SMBL2240 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-02-06 |