FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3010345
·
Received March 19, 2013
Report
- Report Number
- 3005477969-2013-00092
- Event Type
- Injury
- Date Received
- March 19, 2013
- Date of Event
- November 26, 2012
- Report Date
- April 29, 2014
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED IN (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113803 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 54878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R | FEMORAL HEAD, PART# 74121150, LOT# NI |