FDA Adverse Event
Injury
Summary report: N
GRS GLENOID RESURFACING SYSTEM
MDR report key: 2465171
·
Received February 21, 2012
Report
- Report Number
- 3004154314-2012-00001
- Event Type
- Injury
- Date Received
- February 21, 2012
- Date of Event
- February 1, 2012
- Report Date
- February 20, 2012
- Manufacturer
- ARTHROSURFACE, INC.
- Product Code
- KWS
- PMA / PMN Number
- K091196
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUCCESSFUL OUTCOME AND CONVERSION TO TOTAL SHOULDER.
Description of Event or Problem · 1
PERI-PROSTHETIC FRACTURE AFTER GLENOID IMPLANTATION. PT COMPLAINED OF PAIN POST SURGERY AND X-RAY SHOWED POSTERIOR GLENOID FRACTURE AND MIGRATION OF IMPLANT. DISCUSSION WITH REVISING SURGEON INDICATED THAT ARTHROSURFACE HEMICAP SHOULDER AND GLENOID IMPLANTS WERE REMOVED WITHOUT INCIDENT AND CONVERTED TO A STANDARD STEMMED HEMI AND GLENOID. DR. HERRING STATED THAT THE EXCESSIVE POSTERIOR PLACEMENT OF THE GLENOID IMPLANT LEFT INSUFFICIENT BONE FOR A STABLE GLENOID. DR. HERRING WAS SATISFIED WITH THE OUTCOME OF THE CASE AND STATED IT WAS NOT A PRODUCT ISSUE, BUT SURGEON TECHNIQUE. X-RAYS, PHOTOGRAPHS AND IMAGES ON FILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRS GLENOID RESURFACING SYSTEM | NONE | KWS | ARTHROSURFACE, INC. | G203-2015 | 75FK2008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |