FDA Adverse Event
Injury
Summary report: N
NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE
MDR report key: 3252146
·
Received July 25, 2013
Report
- Report Number
- 1822565-2013-01153
- Event Type
- Injury
- Date Received
- July 25, 2013
- Date of Event
- May 5, 2013
- Report Date
- June 27, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
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 PT WAS REVISED DUE TO FRACTURE OF THE POST ON THE ARTICULAR SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348299 | NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE | JWH | ZIMMER, INC. | 60887737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |