FDA Adverse Event
Malfunction
Summary report: N
TM REVERSE GLENOSPHERE DISTRACTOR
MDR report key: 2122010
·
Received May 24, 2011
Report
- Report Number
- 1822565-2011-01237
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 27, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 SURGERY WAS DELAYED FOR 45 MINUTES WHEN THE GLENOSPHERE REMOVAL PLATE BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TM REVERSE GLENOSPHERE DISTRACTOR | HWB | ZIMMER, INC. | 61135953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |