FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2833185
·
Received November 15, 2012
Report
- Report Number
- 3005477969-2012-00385
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- November 7, 2012
- Report Date
- September 24, 2013
- 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 AND ELEVATED METAL ION LEVELS. THE SURGOEN NOTED MILD METALLOSIS AT THE TIME OF REVISION.
Description of Event or Problem · 1
IN (B)(6) 2011 THE PATIENT COMPLAINED OF PAIN IN BOTH HIPS AND REPORTED REDUCED WALKING DISTANCE. IN (B)(6) 2012 THE PATIENT REPORTED NOT BEING ABLE TO WALK MORE THAN HALF MILE WITHOUT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 88299 003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization | MODULAR SLEEVE, (B)(4), LOT# 07LW14593| MODULAR HEAD, (B)(4), LOT# 08HW18617 022 |