FDA Adverse Event
Injury
Summary report: N
CORMET
MDR report key: 4216326
·
Received October 23, 2014
Report
- Report Number
- 9614209-2014-00089
- Event Type
- Injury
- Date Received
- October 23, 2014
- Date of Event
- February 26, 2013
- Report Date
- October 24, 2014
- Manufacturer
- CORIN MEDICAL, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED. 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 4 YRS DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677482 | CORMET | HIP RESURFACING PROSTHESIS | NXT | CORIN MEDICAL, LTD. | 479.248B | LQIE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ASSOCIATED CORMET RESURFACING HEAD 479.042B,| LOT LANI |