FDA Adverse Event
Injury
Summary report: N
ZIMMER TM REVERSE SHOULDER GLENOSPHERE
MDR report key: 3946358
·
Received July 10, 2014
Report
- Report Number
- 1822565-2014-00839
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- October 5, 2012
- Report Date
- June 10, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF THE GLENOSPHERE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404467 | ZIMMER TM REVERSE SHOULDER GLENOSPHERE | HSD | ZIMMER, INC. | 62032987 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ZIMMER TM REVERS SHOULDER BASE PLATE| CAT #00434903811, LOT #62019402 |