FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 4133919
·
Received October 2, 2014
Report
- Report Number
- 3005477969-2014-00514
- Event Type
- Injury
- Date Received
- October 2, 2014
- Date of Event
- December 3, 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
- US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE DEVICES WERE IMPLANTED IN 2009.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF THE ACETABULUM. IT WAS ALSO STATED THAT THE PATIENT HAS ELEVATED BLOOD IONS, EXACT VALUES NOT SUPPLIED TO MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614450 | BHR | ACETABLR CUP HAP 44MM W/ IMPTR | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R |