FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2240712
·
Received September 9, 2011
Report
- Report Number
- 3005477969-2011-00226
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 15, 2011
- Report Date
- November 2, 2011
- 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 DUE TO A LEFT HIP FEMORAL NECK FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | RESURFACING FEMORAL HEAD | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | -080 005 PARTIAL & CORRECTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | ACETABULAR CUP, PART#120152, LOT#568| LOT# 668 (PARTIAL & CORRECTION) |