FDA Adverse Event
Injury
Summary report: N
HTO FIXATION PLATE LT
MDR report key: 249393
·
Received November 12, 1999
Report
- Report Number
- 2935620-1999-00041
- Event Type
- Injury
- Date Received
- November 12, 1999
- Date of Event
- May 1, 1995
- Report Date
- October 12, 1999
- Manufacturer
- SULZER ORTHOPEDICS INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT UNDERWENT A LEFT HTO ON 01/10/1995. ON 06/1995 THE PT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT, LEAVING HER WITH PERMANENT PAIN AND DISABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HTO FIXATION PLATE LT Implant | KNEE PROSTHESIS | HRS | SULZER ORTHOPEDICS INC. | NA | 65124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization| R |