FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 2940444
·
Received February 4, 2013
Report
- Report Number
- 3005477969-2013-00033
- Event Type
- Injury
- Date Received
- February 4, 2013
- Report Date
- September 16, 2013
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE PATIENT'S DEVICES WERE ORIGINALLY IMPLANTED IN 2008, AND WERE REVISED IN (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46212 | R3 | COCR ACETABULAR LINER | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 08KW19572 053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R | MODULAR SLEEVE, # 74222100, LOT # 09BW21799| MODULAR HEAD SLEEVE, PART# 74222100, LOT# UNKNOWN| FEMORAL HEAD, PART#74222140, LOT# UNKNOWN| MODULAR HEAD, # 74222140, LOT # 08JW19051 023 |