FDA Adverse Event
Malfunction
Summary report: N
NEXGEN LCCK ARTICULAR SURFACE
MDR report key: 3061463
·
Received April 10, 2013
Report
- Report Number
- 1822565-2013-00614
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 14, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY INSERTING THE ARTICULAR SURFACE. THE IMPLANT WAS REPLACED WITH ANOTHER ARTICULAR SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149896 | NEXGEN LCCK ARTICULAR SURFACE | JWH | ZIMMER, INC. | 61688807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |