FDA Adverse Event
Malfunction
Summary report: N
MILLER BONE CEMENT INJECTOR FRONT LOADING CARTRIDGE KIT
MDR report key: 1577653
·
Received January 7, 2010
Report
- Report Number
- 1822565-2010-00007
- Event Type
- Malfunction
- Date Received
- January 7, 2010
- Date of Event
- December 1, 2009
- Report Date
- December 9, 2009
- Manufacturer
- ZIMMER, INC.
- Product Code
- KIH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 BONE CEMENT INJECTOR FRACTURED DURING SURGERY CAUSING A ONE HOUR DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLER BONE CEMENT INJECTOR FRONT LOADING CARTRIDGE KIT | BONE CEMENT INSTRUMENTATION | KIH | ZIMMER, INC. | NA | 61218511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |