FDA Adverse Event
Injury
Summary report: N
SULZER ORTHOPEDICS, INC
MDR report key: 350106
·
Received August 30, 2001
Report
- Report Number
- 350106
- Event Type
- Injury
- Date Received
- August 30, 2001
- Date of Event
- August 14, 2001
- Report Date
- August 14, 2001
- Manufacturer
- SULZER ORTHOPEDICS, INC.
- Product Code
- KWB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39491 | SULZER ORTHOPEDICS, INC | ACETABULAR SHELL AND LINER | KWB | SULZER ORTHOPEDICS, INC. | 436000055/INTER-OP | 1431172 | |
| 39492 | SULZER ORTHOPEDICS INC | DOME PLUG AND SCREWS AND FEMORAL HEAD COMPONENT | HSH | SULZER ORTHOPEDICS INC | * | 1429393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |