FDA Adverse Event
Injury
Summary report: N
POR STM TIB B/P LT SZ1 NK II
MDR report key: 330010
·
Received May 3, 2001
Report
- Report Number
- 2935620-2001-00795
- Event Type
- Injury
- Date Received
- May 3, 2001
- Date of Event
- March 31, 2001
- Report Date
- April 4, 2001
- Manufacturer
- SULZER ORTHOPEDICS, INC.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RADIOLUCENICES, REPORTED BY THE SURGEON TO SULZER ORTHOPEDICS, INC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20281 | POR STM TIB B/P LT SZ1 NK II | KNEE PROSTHESIS | HSH | SULZER ORTHOPEDICS, INC. | NA | 1448360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |