FDA Adverse Event
Malfunction
Summary report: N
EQUINOXE HUMERAL HEAD, SHORT
MDR report key: 3941007
·
Received April 23, 2014
Report
- Report Number
- 1038671-2014-00148
- Event Type
- Malfunction
- Date Received
- April 23, 2014
- Date of Event
- March 5, 2014
- Report Date
- April 23, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWS
- Adverse Event
- Yes
- Product Problem
- 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
REVISION OF EQUINOXE SHOULDER SYSTEM COMPONENTS DUE TO LOOSENING. THIS EVENT WAS REPORTED THROUGH CLINICAL DATA COLLECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245292 | EQUINOXE HUMERAL HEAD, SHORT | HUMERAL HEAD | KWS | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |