FDA Adverse Event
Injury
Summary report: N
AEQUALIS KEELED GLENOID UNKNOWN
MDR report key: 4687503
·
Received April 8, 2015
Report
- Report Number
- 9610667-2015-00033
- Event Type
- Injury
- Date Received
- April 8, 2015
- Report Date
- March 19, 2015
- Manufacturer
- TORNIER SAS
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. "WALCH G, MORAGA C, ET AL. (2012). RESULTS OF ANATOMIC NONCONSTRAINED PROSTHESIS IN PRIMARY OSTEOARTHRITIS WITH BICONCAVE GLENOID", J SHOULDER ELBOW SURG, 21:1526-1533.
Description of Event or Problem · 1
DUE TO POSTERIOR PROSTHESIS DISLOCATION, 1 PATIENT PRESENTED WITH LATE POSTERIOR INSTABILITY, UNDERWENT REOPERATIONS AT 3 YRS AFTER THE INDEX SURGERY, AND UNDERWENT GLENOID RECONSTRUCTION AND REVISION TO REVERSE SHOULDER ARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230522 | AEQUALIS KEELED GLENOID UNKNOWN | NONE | HSD | TORNIER SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |