FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER SHOULDER
MDR report key: 3102124
·
Received April 26, 2013
Report
- Report Number
- 1822565-2013-00716
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- September 15, 2011
- Report Date
- March 27, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT EXPERIENCED WOUND DEHISCENCE THAT WAS TREATED (B)(6) 2011. THIS EVENT WAS STATED TO BE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181651 | UNKNOWN ZIMMER SHOULDER | SHOULDER PROSTHESIS | HSD | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |