FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2831177
·
Received November 14, 2012
Report
- Report Number
- 3005477969-2012-00382
- Event Type
- Injury
- Date Received
- November 14, 2012
- Date of Event
- March 20, 2012
- Report Date
- November 14, 2012
- 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. THE DEVICES WERE IMPLANTED IN 2003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD | 21833 40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| R | FEMORAL HEAD, PART #74121150, LOT #21699 40 |