MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-25 for RHEO KNEE RKN130003 manufactured by 3003764610.
[112197789]
The patient has only been using knee for a short period of time and it is known that tf amputees are known to fall more frequently, regardless of product malfunction but with low occurrence of injuries. We received the loaner knee back after incident, we conducted our tests and verification activities, and based on those we haven't found any abnormalities / issues. However, because of the customer reporting that he was injured in this instance, we conducted further analysis to confirm that there is nothing wrong with the knee. That additional analysis have provided no reason to suspect such an issue. This is considered an isolated event in severity of injury.
Patient Sequence No: 1, Text Type: N, H10
[112197790]
A week or two weeks into original knee, started experiencing issues, knee was shuddering (no other issues besides shuddering). Sent primary knee in for servicing and received a loaner knee. While on a loaner knee he fell ((b)(6) 2018) and broke his hip, the next day (b)(6) 2018 received surgery. He was on loaner knee from (b)(6) 2017 until (b)(6) 2018. After fall he went to the hospital; diagnosed with fractured hip; received mri, cat scan and xrays, than emergency surgery next morning. Currently no medication is being utilized, has been attending therapy twice a week and has already completed for a whole month.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2018-00002 |
| MDR Report Key | 7634307 |
| Report Source | CONSUMER |
| Date Received | 2018-06-25 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-06-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR UBALDO ANAYA |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493033239 |
| Manufacturer G1 | OSSUR AMERICAS, INC. |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEO KNEE |
| Generic Name | RHEO KNEE |
| Product Code | ISW |
| Date Received | 2018-06-25 |
| Returned To Mfg | 2018-04-10 |
| Model Number | RKN130003 |
| Catalog Number | RKN130003 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3003764610 |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, REYKJAVIK 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-25 |