FDA Adverse Event
Injury
Summary report: N
NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE
MDR report key: 2802435
·
Received October 19, 2012
Report
- Report Number
- 1822565-2012-02151
- Event Type
- Injury
- Date Received
- October 19, 2012
- Date of Event
- September 20, 2012
- Report Date
- September 20, 2012
- Manufacturer
- ZIMMER INC
- Product Code
- MBH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
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 WHILE DOING A WASH OUT OF THE KNEE DUE TO INFECTION, THE SURGEON REALIZED THAT THE POST OF THE ARTICULAR SURFACE HAD FRACTURED. AS A RESULT, THE SURGEON ELECTED TO EXCHANGE THE SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE | MBH | ZIMMER INC | 60786291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | CATALOG #00598604701, LOT #60796046| ZIMMER (B)(4)| NEXGEN ALL POLY PATELLA, CATALOG #00597206541,| THE FOLLOWING DEVICES WERE MANUFACTURED BY| NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT,| CATALOG #00599601551, LOT #60832053| NEXGEN LPS FEMORAL COMPONENT,| LOT #60258444 |