FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3172166
·
Received June 17, 2013
Report
- Report Number
- 3005477969-2013-00246
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- May 25, 2011
- Report Date
- September 20, 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 HIP AND LEG PAIN, WHICH BEGAN IN 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272798 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 083242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R | FEMORAL HEAD, # 74121146, LOT # 07KW14081 |