FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
MDR report key: 4142789
·
Received September 23, 2014
Report
- Report Number
- 3007963827-2014-00048
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- November 20, 2013
- Report Date
- August 25, 2014
- Manufacturer
- ZIMMER ORTHOPEDIC MFG LTD
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590956 | NEXGEN LPS-FLEX GSF FEMORAL COMPONENT | JWH | ZIMMER ORTHOPEDIC MFG LTD | 61527826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |