FDA Adverse Event
Injury
Summary report: N
RHEO KNEE
MDR report key: 17297020
·
Received July 11, 2023
Report
- Report Number
- 3003764610-2023-00015
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- June 25, 2023
- Report Date
- August 24, 2023
- Manufacturer
- OSSUR HF
- Product Code
- ISW
- UDI-DI
- 05690977467873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT WAS GETTING OUT OF BED WITH THE PROSTHETIC KNEE AND FELL. AS A RESULT OF THE FALL HE HAD A FEMORAL NECK FRACTURE.
Description of Event or Problem · 0
THE PATIENT WAS GETTING OUT OF BED WITH THE PROSTHETIC KNEE AND FELL. AS A RESULT OF THE FALL HE HAD A FEMORAL NECK FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1687651 | RHEO KNEE | PROSTHETIC KNEE | ISW | OSSUR HF | RKNX230 | 05690977467873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| O |