MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-23 for SYMBIONIC KNEE SMBL6280 manufactured by Ossur.
[15155870]
Above knee amputee patient wearing the symbionic knee prosthetic was maneuvering 3 steps and claims the resistance dropped out on the knee and he fell backward hitting his head against a wall resulting in stitches to his head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2013-00002 |
| MDR Report Key | 3329168 |
| Report Source | 05 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-08-23 |
| Date of Event | 2013-08-13 |
| Date Mfgr Received | 2013-08-15 |
| Date Added to Maude | 2013-09-09 |
| 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 DRIVE |
| 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 KNEE |
| Product Code | ISW |
| Date Received | 2013-08-23 |
| Model Number | SMBL6280 |
| Catalog Number | SMBL6280 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2013-08-23 |