FDA Adverse Event
Injury
Summary report: N
NOVATION ELEMENT FEMORAL STEM, 12/14
MDR report key: 4173194
·
Received September 19, 2014
Report
- Report Number
- 1038671-2014-00439
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- August 26, 2014
- Report Date
- September 16, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
REVISION OF HIP COMPONENTS DUE TO SUBOPTIMAL ORIENTATION OF THE ACETABULAR. THE SURGEON DOES NOT CONSIDER REVISION TO BE DEVICE RELATED. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THIS EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES, IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583061 | NOVATION ELEMENT FEMORAL STEM, 12/14 | FEMORAL STEM | JDI | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |