FDA Adverse Event
Injury
Summary report: N
CORMET METAL ON METAL HIP RESURFACING
MDR report key: 1884075
·
Received October 20, 2010
Report
- Report Number
- 9614209-2010-00018
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- September 17, 2010
- Report Date
- September 27, 2010
- Manufacturer
- CORIN LTD
- Product Code
- NXT
- PMA / PMN Number
- P050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
X-RAYS REQUESTED. DEVICE NOT SAVED BY STAFF.
Description of Event or Problem · 1
PATIENT HAD FEMORAL HEAD DEVICE REVISED 5 MONTHS AFTER IMPLANTATION, FOLLOWING FALL AT HOME AND FRACTURE OF THE NECK PORTION OF HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORMET METAL ON METAL HIP RESURFACING | NXT PROST HIP SEMI-CONST MET/MET RESURF | NXT | CORIN LTD | LBVB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | EXPIRATION DATE:| CATALOG# 570-04-052, LOT# LFXT| CORMET ACETABULAR CUP COMPONENT |