FDA Adverse Event
Injury
Summary report: N
ACETLR CUP HAP 46MM W/ IMPTR
MDR report key: 3844482
·
Received June 3, 2014
Report
- Report Number
- 3005477969-2014-00351
- Event Type
- Injury
- Date Received
- June 3, 2014
- Date of Event
- October 2, 2012
- Report Date
- July 12, 2018
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORRED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323841 | ACETLR CUP HAP 46MM W/ IMPTR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 70245 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R | FEMORAL HEAD, PART #74121138 AND LOT #74219 |