FDA Adverse Event
Injury
Summary report: N
CORMET METAL ON METAL HIP RESURFACING
MDR report key: 1604680
·
Received February 1, 2010
Report
- Report Number
- 9614209-2010-00002
- Event Type
- Injury
- Date Received
- February 1, 2010
- Date of Event
- January 22, 2010
- Report Date
- February 1, 2010
- Manufacturer
- CORIN LTD.
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORIN HAS REQUESTED EXPLANT AND FURTHER INFORMATION, MEDICAL RECORDS AND X-RAYS ETC FROM THE FACILITY. NO PATIENT DETAILS KNOWN.
Description of Event or Problem · 1
PATIENT WAS REVISED ABOUT 8 YEARS AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORMET METAL ON METAL HIP RESURFACING | CORMET ACETABULAR CUP COMPONENT | NXT | CORIN LTD. | NOT KNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |