FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2240632
·
Received September 9, 2011
Report
- Report Number
- 3005477969-2011-00223
- Event Type
- Injury
- Date Received
- September 9, 2011
- Report Date
- September 9, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED TO EXCHANGE THE FEMORAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | FEMORAL HEAD | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |