FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN ZIMMER TM REVERSE GLENOSPHERE
MDR report key: 1070979
·
Received July 3, 2008
Report
- Report Number
- 1822565-2008-00395
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Report Date
- June 5, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THERE IS AN ISSUE WITH A TM REVERSE GLENOSPHERE EITHER BEING OFF OR ON AT AN ANGLE. EXACT IMPLANT DATE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ZIMMER TM REVERSE GLENOSPHERE | SHOULDER PROSTHESIS | HSD | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |