FDA Adverse Event
Malfunction
Summary report: N
DEPTH GAUGE SMALL
MDR report key: 2081164
·
Received April 14, 2011
Report
- Report Number
- 1822565-2011-00953
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
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 DEPTH GAUGE MEASURED 2MM LONG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPTH GAUGE SMALL | LXH | ZIMMER, INC. | 56490059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |