FDA Adverse Event
Injury
Summary report: N
AEQUALIS GLENOID RESURFACING HEAD
MDR report key: 2940539
·
Received January 30, 2013
Report
- Report Number
- 9610667-2013-00003
- Event Type
- Injury
- Date Received
- January 30, 2013
- Date of Event
- June 11, 2012
- Report Date
- January 3, 2013
- Manufacturer
- TORNIER INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
ON (B)(6) 2010: IMPLEMENTATION OF THE MEDICAL DEVICE. WEAR AND TEAR OF THE GLENOID CAVITY WITH GLENOID SYMPTOMATIC WITH PAINS. REVISION OF THE RESURFACING HEAD AND REPLACEMENT BY A TCB ANATOMICAL AEQUALIS. DISAPPEARANCE OF PAIN AFTER REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41429 | AEQUALIS GLENOID RESURFACING HEAD | NONE | KWY | TORNIER INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |