FDA Adverse Event
Injury
Summary report: N
STRIDE UNICONDYLAR KNEE
MDR report key: 4892425
·
Received June 30, 2015
Report
- Report Number
- 3010266064-2015-00001
- Event Type
- Injury
- Date Received
- June 30, 2015
- Date of Event
- June 3, 2015
- Report Date
- August 27, 2020
- Manufacturer
- BLUE BELT TECHNOLOGIES INC
- Product Code
- HSX
- PMA / PMN Number
- K123380
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
PATIENT WAS EXPERIENCING KNEE INSTABILITY AND PAIN. SURGEON PERFORMED AN EXCHANGE OF POLY INSERTS TO TIGHTEN THE KNEE INSTABILITY AND CURB THE PAIN. SURGEON ALSO NOTED THAT A CONTRIBUTING FACTOR IN HIS DECISION TO PERFORM A REVISION WAS THE PAINFUL SUBCUTANEOUS SUTURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420679 | STRIDE UNICONDYLAR KNEE | STRIDE UNICONDYLAR KNEE | HSX | BLUE BELT TECHNOLOGIES INC | 6672221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |