FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 3181342
·
Received June 21, 2013
Report
- Report Number
- 3005477969-2013-00258
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- May 9, 2013
- Report Date
- November 13, 2014
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED TO REMOVE AN ACETABULAR LINER AND FEMORAL HEAD, THE ACETABULAR CUP AND FEMORAL STEM REMAIN IMPLANTED. ALL OF THESE DEVICES WERE ORIGINALLY IMPLANTED IN (B)(6) 2009.
Description of Event or Problem · 1
PAIN, WEAKNESS OF THE LEGS AND HIPS, ELEVATED COBALT AND CHROMIUM LEVELS, FLUID ACCUMULATIONS AROUND THE HIP REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282046 | R3 | COCR ACETABULAR LINER | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R | FEMORAL STEM, PART AND LOT# UNKNOWN| ACETABULAR CUP, PART AND LOT# UNKNOWN| FEMORAL HEAD, PART# (B)(4), LOT# UNKNOWN| MODULAR HEAD SLEEVE, PART AND LOT# UNKNOWN |