FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3003851
·
Received March 14, 2013
Report
- Report Number
- 3005477969-2013-00075
- Event Type
- Injury
- Date Received
- March 14, 2013
- Date of Event
- August 18, 2011
- Report Date
- July 8, 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
AROUND (B)(6) 2010 THE PATIENT STARTED EXPERIENCING GROIN PAIN, DIFFICULTY IN WALKING, SWELLING AND OTHER SYMPTOMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO AN ADVERSE REACTION TO METAL DEBRIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106835 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 08MW20685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | FEMORAL HEAD, PART# 74123148, LOT# 08KW19826 |