FDA Adverse Event
Injury
Summary report: N
UNK AVENIR STEM
MDR report key: 3934638
·
Received June 26, 2014
Report
- Report Number
- 9613350-2014-03665
- Event Type
- Injury
- Date Received
- June 26, 2014
- Date of Event
- June 1, 2014
- Report Date
- June 1, 2014
- Manufacturer
- ZIMMER GMBH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER DID NOT RECEIVE THE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WAS CEMENTLESS IMPLANTED WITH A AVENIR STEM (EXACT CATALOGUE NUMBER UNK) ON UNK DATE AND WAS REVISED ON UNK DATE DUE TO STEM SUBSIDENCE (AROUND 1CM).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374927 | UNK AVENIR STEM | UNK AVENIR STEM | JDI | ZIMMER GMBH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |