FDA Adverse Event
Injury
Summary report: N
CORMET RESURFACING HIP SYSTEM
MDR report key: 4951567
·
Received July 28, 2015
Report
- Report Number
- 9614209-2015-00037
- Event Type
- Injury
- Date Received
- July 28, 2015
- Date of Event
- October 27, 2014
- Report Date
- July 27, 2015
- Manufacturer
- CORIN LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE DETAILS, PATIENT 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 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
REVISION OF CORMET CUP AND HEAD AFTER 8YRS 3 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489142 | CORMET RESURFACING HIP SYSTEM | RESURFACING HIP SYSTEM | NXT | CORIN LTD. | 179.258B | JQVH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R | ASSOCIATED CORMET HEAD 179.052B, LOT JSYL |