FDA Adverse Event
Injury
Summary report: N
OMNIFIT EON CS 127 NK SIZE 6 STEM 30 MM NE
MDR report key: 1993472
·
Received February 8, 2011
Report
- Report Number
- 2249697-2011-00116
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K983226
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT WAS REVISED DUE TO ASEPTIC LOOSENING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT EON CS 127 NK SIZE 6 STEM 30 MM NE | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |