FDA Adverse Event
Malfunction
Summary report: N
TM REVERSE SHOULDER LINER IMPACTOR
MDR report key: 2623299
·
Received June 13, 2012
Report
- Report Number
- 1822565-2012-01252
- Event Type
- Malfunction
- Date Received
- June 13, 2012
- Date of Event
- April 30, 2012
- Report Date
- May 14, 2012
- Manufacturer
- ZIMMER INC.
- Product Code
- HSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 UPON IMMEDIATELY REMOVING THE IMPACTOR FROM THE POLY AFTER A FEW MALLET STRIKES TO SEAT THE LINER, IT WAS NOTICED THAT THE ALIGNMENT PIN WAS NOT PRESENT ANYMORE. THE SURGEON SEARCHED THE PT, THE DRAPES, AND THE HOLE IN WHICH THE ALIGNMENT GUIDE GOES INTO. HE WAS UNABLE TO LOCATE IT. THEY SEARCHED THE FLOOR AND WERE ALSO NOT ABLE TO FIND THE ALIGNMENT PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TM REVERSE SHOULDER LINER IMPACTOR | HSD | ZIMMER INC. | 60758647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |