MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-13 for RHEO KNEE * manufactured by Ossur Of Iceland.
[536266]
I have been an amputee for 29 years. About 6 months ago, i decided to try a computerized knee called "rheo knee. " it did not work from the start. I had used a "test knee" for a few days prior to making the decision to purchase one. It worked fine. When the prosthetist tried to get help from the company he was told to "reclibrate the knee. " we did this a number of times. The knee was ( and is) impossible to walk on, and very unsafe. The company eventually sent its reps: while working on my knee they admitted the knee was defective, and that they had been aware that it was shipped from the factory with defective software. They promised to reprogram it and take care of the problem. It was not repaired. In fact, they sent it back after "reprogramming" and it has the identical problem. They told us to "recalibrate the knee. " the knee does not improve when i "recalibrate the knee. " they have sold a defective and dangerous product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040926 |
| MDR Report Key | 780883 |
| Date Received | 2006-11-13 |
| Date of Report | 2006-10-30 |
| Date of Event | 2006-01-01 |
| Date Added to Maude | 2006-11-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEO KNEE |
| Generic Name | COMPUTER CONTROLLED PROSTHETIC KNEE |
| Product Code | ISS |
| Date Received | 2006-11-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 768662 |
| Manufacturer | OSSUR OF ICELAND |
| Manufacturer Address | * * IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-13 |