FDA Adverse Event
Injury
Summary report: N
AEQUALIS KEELED GLENOID UNKNOWN
MDR report key: 4687521
·
Received April 8, 2015
Report
- Report Number
- 9610667-2015-00026
- Event Type
- Injury
- Date Received
- April 8, 2015
- Report Date
- March 19, 2015
- Manufacturer
- TORNIER SAS
- Product Code
- KWS
- 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 GLENOID LOOSENING, 1 PATIENT HAD GLENOID RECONSTRUCTION WITH A STRUCTURAL TRICORTICAL ILIAC CREST BONE GRAFT AND HEMIARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230622 | AEQUALIS KEELED GLENOID UNKNOWN | NONE | KWS | TORNIER SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |