MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-02-06 for RHEO KNEE 3 RKN130002 manufactured by Ossur Iceland.
[66599547]
Device evaluation under way, not complete.
Patient Sequence No: 1, Text Type: N, H10
[66599548]
Amputee patient wearing a rheo knee 3 was walking down stairs and claimed the unit failed causing him to fall on his back. The patient had medical treatment for two weeks after falling and had a back soft tissue bruise and spinous process of the thoracic spine.
Patient Sequence No: 1, Text Type: D, B5
[69770864]
Patient Sequence No: 1, Text Type: N, H10
[69770865]
Amputee patient wearing a rheo knee 3 was walking down stairs and claimed the unit failed causing him to fall on his back. The patient had medical treatment for two weeks after falling and had a back soft tissue bruise and spinous process of the thoracic spine. He also had radiculitis exacerbation as a result. He recovered without complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2017-00001 |
| MDR Report Key | 6304078 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-02-06 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-01-02 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEO KNEE 3 |
| Generic Name | PROSHTETIC KNEE |
| Product Code | ISW |
| Date Received | 2017-02-06 |
| Returned To Mfg | 2017-01-23 |
| Model Number | RKN130002 |
| Catalog Number | RKN130002 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-06 |