FDA Adverse Event
Injury
Summary report: N
CORMET RESURFACING
MDR report key: 4574765
·
Received May 16, 2014
Report
- Report Number
- 9614209-2014-00050
- Event Type
- Injury
- Date Received
- May 16, 2014
- Date of Event
- July 28, 2010
- Report Date
- May 16, 2014
- Manufacturer
- CORIN MEDICAL, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - INITIAL REPORT. DEVICE DETAILS, PT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MFG RECORDS TO BE REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER. THIS EVENT OCCURRED OUTSIDE OF THE USA.
Description of Event or Problem · 1
CORMET REVISION AFTER 2 YEARS 7 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295151 | CORMET RESURFACING | METAL ON METAL RE-SURFACING | NXT | CORIN MEDICAL, LTD. | 179.254B | KNAX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | ASSOCIATED CORMET RESURFACING HEAD 179.48,| LOT KFKG |