FDA Adverse Event
Death
Summary report: N
BHR
MDR report key: 2962966
·
Received February 15, 2013
Report
- Report Number
- 3005477969-2013-00053
- Event Type
- Death
- Date Received
- February 15, 2013
- Date of Event
- February 14, 2013
- Report Date
- April 23, 2013
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED.
Description of Event or Problem · 1
REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. THE PATIENT INVOLVED IN THE REVISION HAD RAPDILY METASTIZISING LUNG CANCER. THE PATIENT DIED IMMEDIATELY AFTER IMPLANTATION OF REVISION IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66822 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 76540 026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death| H| R | FEMORAL HEAD, PART# 74121146, LOT# 76772 051| FEMORAL HEAD, PART AND LOT# UNKNOWN |