FDA Adverse Event
Injury
Summary report: N
CORMET RESURFACING
MDR report key: 4584665
·
Received June 17, 2014
Report
- Report Number
- 9614209-2014-00055
- Event Type
- Injury
- Date Received
- June 17, 2014
- Date of Event
- January 28, 2013
- Report Date
- June 17, 2014
- Manufacturer
- CORIN MEDICAL, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4) INITIAL REPORT: DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT ND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS TO BE REVIEWED. THE CORMET CUP AND CORMET HEAD WERE INSERTED DURING A REVISION PROCEDURE TO REPLACE A ZWEYMULLER ENDOPLUS TOTAL HIP REPLACEMENT, HOWEVER ZWEYMULLER STEM WAS RETAINED AND USED IN CONJUNCTION WITH THE CORMET DEVICES. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.
Description of Event or Problem · 1
CORMET REVISION AFTER 6 YEARS AND 10 MONTHS DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356922 | CORMET RESURFACING | METAL ON METAL RESURFACING | NXT | CORIN MEDICAL, LTD. | 179.254B | JLRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | E079.948: LOT IYMZ| ASSOCIATED EUROCONE CORMET MODULAR ENDO HEAD |