FDA Adverse Event
Injury
Summary report: N
TOTAL KNEE 2000
MDR report key: 22477595
·
Received July 11, 2025
Report
- Report Number
- 3003764610-2025-00005
- Event Type
- Injury
- Date Received
- July 11, 2025
- Report Date
- November 17, 2025
- Manufacturer
- OSSUR HF
- Product Code
- ISY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
REPORTED ISSUE WAS THAT THE KNEE COLLAPSED AND USER FELL WHEN STEPPING OVER DOOR THRESHOLD AND SUSTAINED A BROKEN ARM. THERE WAS NO ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE. NO DEVICE WAS RETURNED, AND THE LIMITED REPORTED INFORMATION LEFT THE ROOT CAUSE DETERMINATION UNVERIFIED.
Description of Event or Problem · 0
USER WAS STEPPING DOWN OUT OF A DOOR THRESHOLD WHEN SHE FELL AND BROKE HER ARM.
Description of Event or Problem · 0
USER WAS STEPPING DOWN OUT OF A DOOR THRESHOLD WHEN SHE FELL AND BROKE HER ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 762666 | TOTAL KNEE 2000 | PROSTHETIC KNEE | ISY | OSSUR HF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |