FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 3604902
·
Received February 4, 2014
Report
- Report Number
- 3005477969-2014-00125
- Event Type
- Injury
- Date Received
- February 4, 2014
- Date of Event
- November 3, 2011
- Report Date
- February 13, 2014
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL AND CORRECTED DATA: IT HAS BEEN DETERMINED THAT THE EVENT AND DETAILS OF THIS REPORT ARE A DUPLICATE OF AN EARLIER REPORT, 1020279-2011-00519. PLEASE DISREGARD THIS REPORT AND REFERENCE 1020279-2011-00519.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, WEAKNESS OF THE LEGS AND HIPS, ELEVATED COBALT AND CHROMIUM LEVELS, AND FLUID ACCUMULATIONS AROUND THE HIP.
Description of Event or Problem · 1
IT HAS BEEN DETERMINED THAT THE EVENT AND DETAILS OF THIS REPORT ARE A DUPLICATE OF AN EARLIER REPORT, 1020279-2011-00519. PLEASE DISREGARD THIS REPORT AND REFERENCE 1020279-2011-00519.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73225 | R3 | COCR ACETABULAR LINER | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | FEMORAL HEAD, PART AND LOT # UNKNOWN| ACETABULAR SHELL, PART AND LOT # UNKNOWN |