FDA Adverse Event
Injury
Summary report: N
EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT
MDR report key: 3874927
·
Received June 10, 2014
Report
- Report Number
- 1038671-2014-00223
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- November 1, 2011
- Report Date
- June 6, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.
Description of Event or Problem · 1
PATIENT PRESENTED WITH A SIGNIFICANT PAIN AND LOSS OF MOTION FOR THE LAST 8-9 MONTHS PRIOR TO INCISION AND DRAINAGE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338365 | EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT | HUMERAL STEM | HSD | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |