FDA Adverse Event
Injury
Summary report: N
ZIMMER CLAMP FOOT
MDR report key: 3908302
·
Received June 13, 2014
Report
- Report Number
- 1822565-2014-00753
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 15, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- HXD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 O-RING CAME OFF AND REMAINED IN THE PT. A REVISION SURGERY IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350609 | ZIMMER CLAMP FOOT | HXD | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |