FDA Adverse Event
Malfunction
Summary report: N
DEPTH GUAGE PELVIC SMALL
MDR report key: 2061514
·
Received March 16, 2011
Report
- Report Number
- 1822565-2011-00641
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 17, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 THAT THE SHORT DEPTH GAUGE HAD BEEN ASSEMBLED WITH A LONG DEPTH GAUGE CAP. THIS RESULTED IN THE SURGEON IMPLANTING LONGER SCREWS AND THEN HAVING TO REMOVE THEM SO HE COULD IMPLANT THE APPROPRIATE SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPTH GUAGE PELVIC SMALL | LXH | ZIMMER, INC. | 56476175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | DEPTH GAUGE SMALL: CATALOG #00481000201, LOT #UNK |