MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-13 for RHEO KNEE 3 WP RKN13140 manufactured by Ossur H/f.
[94727066]
Above knee amputee patient wearing a rheo knee 3 prosthetic knee fell on left side and hit his head on a door. As a result of the fall, the patient suffered a broken shoulder, injured back, neck and left side of hip. Left shoulder and hip surgery performed on (b)(6) 2017. Patient scheduled for back surgery on (b)(6) 2018. Patient claims that during the fall the prosthesis twisted and the socket came loose. Patient is receiving pain injections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2017-00005 |
| MDR Report Key | 7113365 |
| Report Source | CONSUMER |
| Date Received | 2017-12-13 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-12-13 |
| 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 | PATIENT |
| 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 |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR H/F |
| 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 WP |
| Generic Name | PROSTHETIC KNEE |
| Product Code | ISW |
| Date Received | 2017-12-13 |
| Model Number | RKN13140 |
| Catalog Number | RKN13140 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-13 |