FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3230981
·
Received July 17, 2013
Report
- Report Number
- 3005477969-2013-00291
- Event Type
- Injury
- Date Received
- July 17, 2013
- Date of Event
- February 28, 2006
- Report Date
- July 17, 2013
- 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 PERIPROSTHETIC FRACTURE. THE ACETABULAR CUP REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331778 | BHR | FEMORAL HEAD | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R | ACETABULAR CUP, PART # 120150, LOT # 7122 33 |