FDA Adverse Event
Injury
Summary report: N
TM GLENOID 52MM
MDR report key: 3124031
·
Received May 15, 2013
Report
- Report Number
- 3005751028-2013-00030
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- April 8, 2013
- Report Date
- May 15, 2013
- Manufacturer
- ZIMMER TMT
- Product Code
- KWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT REC'D A TM GLENOID ON (B)(6) 2011. ON (B)(6 )2013, THE PT WAS REVISED WITH ANOTHER DEVICE DUE TO BREAKAGE OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214564 | TM GLENOID 52MM | TM GLENOID | KWS | ZIMMER TMT | 61826545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |