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 2019-01-16 for RHEO KNEE XC RKNXC0005 manufactured by Ossur Hf.
[133215000]
Based on information currently available no analysis possible. Knee has been returned and is in transit to the ossur quality centre for evaluation. Circumstances and injury details are under investigation.
Patient Sequence No: 1, Text Type: N, H10
[133215001]
Knee is failing to lock when weight activated, patient fell and has broken his femur on amputated side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2019-00001 |
| MDR Report Key | 8252100 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-16 |
| Date of Report | 2019-02-12 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-16 |
| 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 XC |
| Generic Name | PROSTHETIC KNEE |
| Product Code | ISW |
| Date Received | 2019-01-16 |
| Model Number | RKNXC0005 |
| Catalog Number | RKNXC0005 |
| 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 HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-16 |