FDA Adverse Event
Injury
Summary report: N
ZIMMER TRABECULAR METAL REVERSE GLENOSPHERE
MDR report key: 3201967
·
Received June 26, 2013
Report
- Report Number
- 1822565-2013-01022
- Event Type
- Injury
- Date Received
- June 26, 2013
- Date of Event
- May 24, 2013
- Report Date
- May 29, 2013
- Manufacturer
- ZIMER INC
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO A DISASSOCIATED GLENOSPHERE. THE SURGEON ATTEMPTED TO RE-IMPLANT THE ITEM WITH OUT SUCCESS. A NEW GLENOSPHERE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291352 | ZIMMER TRABECULAR METAL REVERSE GLENOSPHERE | HSD | ZIMER INC | 62316784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |