MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-12 for RHEO KNEE 3 RKN13110 manufactured by Ossur Hf.
[135876368]
Patient fell and the femur head broke. Patient has weakened bones due to cancer. The injury has healed completely and the patient is doing fine. The device has been analyzed and no product malfunction was identified.
Patient Sequence No: 1, Text Type: N, H10
[135876369]
The patient fell and broke the femur head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2019-00004 |
| MDR Report Key | 8331131 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-12 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEO KNEE 3 |
| Generic Name | PROSTHETIC KNEE |
| Product Code | ISW |
| Date Received | 2019-02-12 |
| Model Number | RKN13110 |
| Catalog Number | RKN13110 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-02-12 |