FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT
MDR report key: 4626343
·
Received March 20, 2015
Report
- Report Number
- 1822565-2015-00368
- Event Type
- Injury
- Date Received
- March 20, 2015
- Report Date
- February 17, 2015
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00167-014-3278-9. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THREE NEXGEN LPS-FLEX KNEE SYSTEMS WERE REVISED DUE TO ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191754 | UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |