FDA Adverse Event
Malfunction
Summary report: N
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE
MDR report key: 753052
·
Received July 26, 2006
Report
- Report Number
- 1822565-2006-00181
- Event Type
- Malfunction
- Date Received
- July 26, 2006
- Date of Event
- June 27, 2006
- Report Date
- June 30, 2006
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWR
- Removal / Correction Number
- 1822565-7/12/06-003-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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 ON JUNE 27, 2006, THE GLENOSPHERE WOULD NOT ENGAGE THE TAPER OF THE BASE PLATE. THE POLY SPACER WAS WASTED BECAUSE THE SURGEON COULD NOT PLACE THE NEW SPHERE WITH REMOVING THE POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE | SHOULDER PROSTHESIS | KWR | ZIMMER, INC. | NA | 60385310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |