FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 2192050
·
Received August 4, 2011
Report
- Report Number
- 1020279-2011-00299
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- August 12, 2010
- Report Date
- July 12, 2011
- Manufacturer
- SMITH AND NEPHEW, INC
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- MEDICAL ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PEFORMED DUE TO IMPLANT FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R3 | ACETABULAR LINER | LZO | SMITH AND NEPHEW, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |