FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3920991
·
Received July 9, 2014
Report
- Report Number
- 3005477969-2014-00383
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- January 3, 2014
- Report Date
- July 8, 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 DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401355 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 53661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| R | MODULAR HEAD, PART #74121246, LOT #52031 |