FDA Adverse Event
Other
Summary report: N
NXT METAL ON METAL RE-SURFACING
MDR report key: 3660390
·
Received January 29, 2014
Report
- Report Number
- 9614209-2014-00003
- Event Type
- Other
- Date Received
- January 29, 2014
- Date of Event
- June 1, 2011
- Report Date
- January 29, 2014
- Manufacturer
- CORIN 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
CAPA (B)(4). PT NOTES, MEDICAL HISTORY, DEVICE DETAILS, EXPLANT AND X-RAYS HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE HISTORY RECORDS TO BE REVIEWED.
Description of Event or Problem · 1
CORMET REVISION DUE TO PAIN, LOOSENING AND POSSIBLE ALVAL AFTER SIX YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62623 | NXT METAL ON METAL RE-SURFACING | CORMET RESURFACING | NXT | CORIN LTD | 179.254B | IGNU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | ASSOCIATED CORMET HEAT 179.048, LOT HTJA |