MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for OTTOBOCK X3 KNEE UNIT I DO NOT HAVE THE KNEE ANYMORE manufactured by Ottobock Se & Co. Kgaa Formerly Known As Otto Bock Healthcare.
[135881491]
I am an above the knee amputee. I have the ottobock x3 knee unit with anti stumble technology. I went out to feed my fish and my prosthetic foot caught a rock and i stumbled. I fell straight down on my femur and it drove into the ground. I hit so hard it snapped a? Inch titanium rod in the knee unit. My prosthetic leg was rendered unusable. I had to crawl. 25 miles back to my house. I was in excruciating pain and went around on crutches for 4 days while my prosthetic guy got a replacement. Ottobock shipped over an inferior product and sent my knee to (b)(4) for further testing. They were all concerned about what happened to me because they knew their product did not work as it was promised. They have had my knee for over two months now and have not provided update. The anti stumble feature is garbage and should be investigated. I have fallen many times because of this: in driveway, house, stairs etc. Now from the fall i am having problems with my limb and have to return to the trauma surgeon. The limb has had sharp pain in it since the fall. I live alone, so i was on crutches or in a wheelchair until the replacement was sent. Please investigate my claim. Ottobock has my knee and i am sure they have extensive information from the computer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083730 |
| MDR Report Key | 8310703 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-12-14 |
| Date Added to Maude | 2019-02-06 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTTOBOCK X3 KNEE UNIT |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL |
| Product Code | ISW |
| Date Received | 2019-02-05 |
| Model Number | I DO NOT HAVE THE KNEE ANYMORE |
| Catalog Number | I DO NOT HAVE THE KNEE ANYMORE |
| Lot Number | I DO NOT HAVE THE KNEE ANYMORE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTOBOCK SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-02-05 |