FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3020550
·
Received March 26, 2013
Report
- Report Number
- 3005477969-2013-00112
- Event Type
- Injury
- Date Received
- March 26, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 28, 2014
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESURFACING FEMORAL HEAD REMAINED IMPLANTED, AND ONLY ACETABULAR CUP WAS REVISED.
Description of Event or Problem · 1
THE PATIENT REPORTED JAMMING HER LEG WHILE ON A MOWER IN (B)(6) OF 2012, SHE HAD PAIN IN HER LEFT LEG SINCE THEN. MARS MRI REPORTEDLY SHOWED SYNOVITIS AND EFFUSION. THE SURGEON DOES NOT FAULT THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE ACETABULAR CUP BEING MISALIGNED. LEG SWELLING AND ELEVATED METAL ION LEVELS REPORTED. THE DEVICE WAS IMPLANTED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124538 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 86019 010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R |