FDA Adverse Event
Injury
Summary report: N
KINECTIV 12/14 NECK TAPER
MDR report key: 2841956
·
Received November 14, 2012
Report
- Report Number
- 1822565-2012-02336
- Event Type
- Injury
- Date Received
- November 14, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 16, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE CORROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINECTIV 12/14 NECK TAPER | KWA | ZIMMER, INC. | 61559672 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Male | Required Intervention | VERSYS FEMORAL HEAD, CATALOG #00801803202, LOT #61558174, MANUFACTURED BY ZIMMER B.V., PONCE, PR.| CATALOG #00801803202, LOT #61558174| MANUFACTURED BY ZIMMER (B)(4)| VERSYS FEMORAL HEAD: |