FDA Adverse Event
Injury
Summary report: N
NEXGEN CR PEGGD TIBIAL COMPONENT
MDR report key: 2875143
·
Received December 12, 2012
Report
- Report Number
- 1822565-2012-02532
- Event Type
- Injury
- Date Received
- December 12, 2012
- Date of Event
- October 31, 2012
- Report Date
- November 12, 2012
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, TIBIAL BASEPLATE SUBSIDENCE, AND TIBIAL COMPONENT LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN CR PEGGD TIBIAL COMPONENT | NONE | JWH | ZIMMER INC | 61315755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | CATALOG #00595203010, LOT #UNK| NEXGEN CR-FLEX PROLONG ARTICULAR SURFACE: |