FDA Adverse Event
Other
Summary report: N
CORMET RESURFACING
MDR report key: 3772780
·
Received February 28, 2014
Report
- Report Number
- 9614209-2014-00007
- Event Type
- Other
- Date Received
- February 28, 2014
- Date of Event
- June 11, 2013
- Report Date
- February 28, 2014
- Manufacturer
- CORIN MEDICAL, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT CNL FB-29. THE IMPLANT HAS BEEN REVISED DUE TO CUP MIGRATION. DEVICE RELATED DOCUMENTATION HAS BEEN REQUESTED.
Description of Event or Problem · 1
CORMET REVISION DUE TO ARMD DUE TO MIGRATION OF IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125050 | CORMET RESURFACING | NXT METAL ON METAL RE-SURFACING | NXT | CORIN MEDICAL, LTD. | 179.254B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R | ASSOCIATED CORMET HEAD 179.048B. |