FDA Adverse Event
Injury
Summary report: N
EQUINOXE REVERSE 42MM GLENOSPHERE
MDR report key: 1241080
·
Received November 21, 2008
Report
- Report Number
- 1038671-2008-00052
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 8, 2008
- Report Date
- November 13, 2008
- Manufacturer
- EXACTECH, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ENGINEERING ANALYSIS OF THE RECOVERED DEVICES SHOWED NO EVIDENCE OF MECHANICAL FAILURE OF THE HUMERAL LINER/HUMERAL TRAY LOCKING MECHANISM. A FUNCTIONAL TEST WAS CONDUCTED ON THE LOCKING MECHANISM FOLLOWING IMPACTION AS INSTRUCTED IN THE SURGICAL TECHNIQUE, THE HUMERAL LINER SUCCESSFULLY LOCKED INTO THE HUMERAL TRAY AS INTENDED.
Description of Event or Problem · 1
PATIENT FELL AND THE HUMERAL LINER DISASSOCIATED FROM THE HUMERAL TRAY REQUIRING REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EQUINOXE REVERSE 42MM GLENOSPHERE | GLENOSPHERE | HSD | EXACTECH, INC. | 23183017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R |