FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2031593
·
Received March 28, 2011
Report
- Report Number
- 3005477969-2011-00073
- Event Type
- Injury
- Date Received
- March 28, 2011
- Date of Event
- December 14, 2010
- Report Date
- June 29, 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
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE REASON FOR REVISION WAS PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. THE REASON FOR REVISION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 63157 028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization| R | FEMORAL HEAD, PART # 74121150, LOT # 63621 |