MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for POWER KNEE PKN120007 manufactured by Ossur Iceland.
[45961808]
Device evaluation anticipated upon receipt of product.
Patient Sequence No: 1, Text Type: N, H10
[45961809]
Prosthetist reports that the amputee patient fell in his home on tuesday, (b)(6) 2016. Patient was wearing the power knee prosthesis. He was standing on flat ground, not taking a step, and claims it felt like the knee buckled which caused him to lose his balance and fall backwards. The patient hit his head during the fall. No medical attention was sought immediately following the incident. However, the patient recently visited his doctor and was diagnosed with a concussion.
Patient Sequence No: 1, Text Type: D, B5
[47926548]
Upon product evaluation, it was determined this is not a reportable event. No product malfunction was identified that could have contributed to the incident.
Patient Sequence No: 1, Text Type: N, H10
[47926549]
Prosthetist reports that the amputee patient fell in his home on tuesday, (b)(6) 2016. Patient was wearing the power knee prosthesis. He was standing on flat ground, not taking a step, and claims it felt like the knee buckled which caused him to lose his balance and fall backwards. The patient hit his head during the fall. No medical attention was sought immediately following the incident. However, the patient recently visited his doctor and was diagnosed with a concussion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00006 |
| MDR Report Key | 5680350 |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-05-24 |
| Date Added to Maude | 2016-05-25 |
| 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 |
| 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 DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR ICELAND |
| 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 | POWER KNEE |
| Generic Name | EXTERNAL ASSEMBLED LOWER LIMB PROSTHESIS |
| Product Code | ISW |
| Date Received | 2016-05-25 |
| Returned To Mfg | 2016-06-02 |
| Model Number | PKN120007 |
| Catalog Number | PKN120007 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-25 |