FDA Adverse Event
Malfunction
Summary report: N
NEXGEN LCCK FEMORAL COMPONENT
MDR report key: 2193411
·
Received July 13, 2011
Report
- Report Number
- 1822565-2011-01651
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 17, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 COMPLETED.
Description of Event or Problem · 1
IT IS REPORTED THAT UPON OPENING THE DEVICE, IT WAS NOTICED THAT BOTH OF THE INTERNAL STERILITY SEALS WERE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LCCK FEMORAL COMPONENT | JWH | ZIMMER INC | 61081775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |