FDA Adverse Event
Injury
Summary report: N
RENOVATION
MDR report key: 781007
·
Received November 13, 2006
Report
- Report Number
- 1020279-2006-00642
- Event Type
- Injury
- Date Received
- November 13, 2006
- Report Date
- October 10, 2006
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
- Product Code
- LZV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A REVISION SURGERY, IT WAS REPORTED THAT OR TIME WAS EXTENDED MORE THAN 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENOVATION | FEMORAL COMPONENT | LZV | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV | UNK | 05MM07238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| O| R |