FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3251505
·
Received July 29, 2013
Report
- Report Number
- 3005477969-2013-00317
- Event Type
- Injury
- Date Received
- July 29, 2013
- Report Date
- March 26, 2014
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352399 | BHR | ACETLR CUP HAP 50MM W/ IMPTR | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 1553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | 74121142 - RESUR FEM HD 42MM -5737 40| FEMORAL HEAD, PART AND LOT# UNKNOWN |