FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 1153073
·
Received September 8, 2008
Report
- Report Number
- 3005477969-2008-00066
- Event Type
- Injury
- Date Received
- September 8, 2008
- Report Date
- September 8, 2008
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD., UK
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. PT WAS IMPLANTED FOR APPROX 18 MOS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | RESURFACING FEMORAL HEAD | KWY | SMITH & NEPHEW ORTHOPAEDICS LTD., UK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R | ACETABULAR CUP |