FDA Adverse Event
Injury
Summary report: N
CORMET METAL ON METAL HIP SURFACING
MDR report key: 1612449
·
Received February 22, 2010
Report
- Report Number
- 9614209-2010-00003
- Event Type
- Injury
- Date Received
- February 22, 2010
- Date of Event
- January 11, 2010
- Report Date
- January 29, 2010
- Manufacturer
- CORIN, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT WAS REVISED ABOUT 8 YEARS AFTER IMPLANTATION AS THE ACETABULAR CUP WAS LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORMET METAL ON METAL HIP SURFACING | CORMET ACETABULAR CUP COMPONENT | NXT | CORIN, LTD. | FKTT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |