FDA Adverse Event
Other
Summary report: N
NATURAL KNEE TIBIA INSERT LEFT SIZE A/7MM
MDR report key: 65047
·
Received January 28, 1997
Report
- Report Number
- 2935620-1997-00001
- Event Type
- Other
- Date Received
- January 28, 1997
- Date of Event
- November 20, 1996
- Report Date
- January 21, 1997
- Manufacturer
- INTERMEDICS ORTHOPEDICS, INC.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NOTICE OF IDE REVISION - G870035.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL KNEE TIBIA INSERT LEFT SIZE A/7MM Implant | KNEE IMPLANT PROSTHESIS | HSH | INTERMEDICS ORTHOPEDICS, INC. | NA | 10709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| O| R | 6201-00-030| 6201-00-120| 6201-00-001 |