FDA Adverse Event
Injury
Summary report: N
SPECIAL NKI POROUS TI FEMUR SIZE 2, LEFT
MDR report key: 385290
·
Received March 29, 2002
Report
- Report Number
- 2935620-2002-00077
- Event Type
- Injury
- Date Received
- March 29, 2002
- Date of Event
- February 28, 2002
- Report Date
- February 28, 2002
- Manufacturer
- SULZER ORTHOPEDICS, INC.
- Product Code
- HSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED: PATIENT WAS REVISED IN 2002 FOR PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECIAL NKI POROUS TI FEMUR SIZE 2, LEFT | CUSTOM PROSTHESIS | HSA | SULZER ORTHOPEDICS, INC. | NA | 1225-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R | SZ 1/2 LT (LOT#1210-01) (2002).| 6307-00-220, NK II NP STM TIB B/P LT SZ 2| (LOT#1345653) (2002) 03-50180-11, CUSTOM TIB INS |