FDA Adverse Event
Injury
Summary report: N
RESURFACING
MDR report key: 4143404
·
Received October 6, 2014
Report
- Report Number
- 1020279-2014-00616
- Event Type
- Injury
- Date Received
- October 6, 2014
- Report Date
- October 6, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING/OSTEOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622677 | RESURFACING | JRNY BCS PAT RESRF RD 38 MM STD | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) |