FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT
MDR report key: 4626323
·
Received March 20, 2015
Report
- Report Number
- 1822565-2015-00366
- Event Type
- Injury
- Date Received
- March 20, 2015
- Report Date
- February 17, 2015
- Manufacturer
- ZIMMER, INC.
- Product Code
- MBH
- 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://JBJS.ORG/CONTENT/96/21/1807. 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 INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190513 | UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT | KNEE PROSTHESIS | MBH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |