FDA Adverse Event
Injury
Summary report: N
UNK COONRAD/MORREY ULNA
MDR report key: 1113151
·
Received August 12, 2008
Report
- Report Number
- 1822565-2008-00512
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- September 17, 2005
- Report Date
- July 2, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
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 THE PT WAS REVISED AT THE CLINIC. IMPLANT DATE WAS 2005 AND EXPLANT DATE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK COONRAD/MORREY ULNA | ELBOW PROSTHESIS | JDB | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |