FDA Adverse Event
Other
Summary report: N
CORMET RESURFACING
MDR report key: 3022612
·
Received March 22, 2013
Report
- Report Number
- 9614209-2013-00007
- Event Type
- Other
- Date Received
- March 22, 2013
- Date of Event
- March 3, 2011
- Report Date
- February 26, 2013
- Manufacturer
- CORIN LTD
- Product Code
- NXT
- PMA / PMN Number
- K082525
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION TO BE REQUESTED. INCIDENT IS OUTSIDE USA.
Description of Event or Problem · 1
CORMET REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119081 | CORMET RESURFACING | NXT METAL ON METAL RE-SURFACING | NXT | CORIN LTD | 179.252B | LBNX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization | ASSOCIATED CORMET HEAD - 179.004. LOT LTCR |