FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER SHOULDER
MDR report key: 4223313
·
Received October 29, 2014
Report
- Report Number
- 1822565-2014-01504
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- July 28, 2014
- Report Date
- October 1, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THE PATIENT WAS REVISED DUE TO IMPLANT BREAKAGE AND PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691327 | UNKNOWN ZIMMER SHOULDER | SHOULDER PROSTHESIS | HSD | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |