FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 1840589
·
Received September 22, 2010
Report
- Report Number
- 3005477969-2010-00133
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- December 17, 2008
- Report Date
- September 22, 2010
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P0040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 |
|---|---|---|---|---|---|---|---|
| 1 | BHR | RESURFACING FEMORAL HEAD | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 25329 196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| R | ACETABULAR CUP, EXACT PART & LOT# UNKNOWN |