FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 2871318
·
Received December 13, 2012
Report
- Report Number
- 3005477969-2012-00423
- Event Type
- Injury
- Date Received
- December 13, 2012
- Date of Event
- December 4, 2012
- Report Date
- June 12, 2013
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FEMORAL STEM AND ACETABULAR SHELL REMAIN IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL IONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R3 | COCR ACETABULAR LINER | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 07GW12871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R | MODULAR HEAD SLEEVE, PART AND LOT# UNKNOWN| FEMORAL HEAD, PART#74222140, LOT# UNKOWN |