FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS ARTICULAR SURFACE
MDR report key: 2871510
·
Received December 6, 2012
Report
- Report Number
- 1822565-2012-02490
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- October 26, 2012
- Report Date
- November 9, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 WAS REPORTED THAT THE PT HAD A LARGE AMOUNT OF KNEE SWELLING AND LOCALIZED PAIN POSTERIORLY. THE PT UNDERWENT ASPIRATION AND 50CC OF PURULENT FLUID WAS TAKEN FROM THE KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS ARTICULAR SURFACE | JWH | ZIMMER, INC. | 60334226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | NEXGEN OFFSET STEM EXTENSION:| CATALOG #00598801017, LOT #60939637| NEXGEN STEMMED TIBIAL COMPONENT:| NEXGEN ANTERIOR FEMORAL AUGMENT BLOCK:| MANUFACTURED AT ZIMMER (B)(4)| NEXGEN STRAIGHT STEM EXTENSION:| (B)(4)| NEXGEN LCCK FEMORAL COMPONENT:| CATALOG #00599401692, LOT #61411989| MANUFACTURED AT ZIMMER (B)(4)| CATALOG #00598802016, LOT #61285534| CATALOG #00598005701, LOT #61307736| NEXGEN ALL POLY PATELLA: CATALOG #00597206541,| CATALOG #00599003631, LOT #60785664| LOT #61407366, MANUFACTURED AT ZIMMER |