FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 4192497
·
Received October 22, 2014
Report
- Report Number
- 3005477969-2014-00541
- Event Type
- Injury
- Date Received
- October 22, 2014
- Date of Event
- September 24, 2014
- Report Date
- October 22, 2014
- Manufacturer
- SMITH & NEPHEW
- 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 |
|---|---|---|---|---|---|---|---|
| 672223 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | FEMORAL HEAD, PART AND LOT # UNKNOWN |