FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2962936
·
Received February 15, 2013
Report
- Report Number
- 3005477969-2013-00052
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- December 7, 2012
- Report Date
- September 2, 2013
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE REVISION SURGERY WAS PERFORMED. PAIN, PROGRESSIVE SLOW MIGRATION OF THE FEMORAL COMPONENT, WITH POSSIBLE COLLAPSE OF THE FEMORAL HEAD REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68054 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 74015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R | FEMORAL HEAD PART#121158, LOT # 9185 |