FDA Adverse Event
Malfunction
Summary report: N
ITST FIXATION COMPRESSION RETAINER
MDR report key: 2151594
·
Received June 24, 2011
Report
- Report Number
- 1822565-2011-01501
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 22, 2011
- Report Date
- May 27, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 ITST CANNULATED RETAINING SHAFT CIRCULAR KNOB CAME OFF THE SHAFT WHILE IMPLANTING THE LAG SCREW. THIS CAUSED THE SURGEON TO NOT BE ABLE TO COMPRESS THE FEMORAL NECK FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITST FIXATION COMPRESSION RETAINER | LXH | ZIMMER INC | 60633134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |