FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2940445
·
Received February 4, 2013
Report
- Report Number
- 3005477969-2013-00034
- Event Type
- Injury
- Date Received
- February 4, 2013
- Report Date
- February 4, 2013
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND SUBLUXATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46937 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 90262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Hospitalization| R | FEMORAL HEAD, PART# 74121146, LOT# 87690 |