FDA Adverse Event
Other
Summary report: N
3DKNEE
MDR report key: 1230281
·
Received November 7, 2008
Report
- Report Number
- 1644408-2008-00404
- Event Type
- Other
- Date Received
- November 7, 2008
- Date of Event
- October 27, 2008
- Report Date
- October 28, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSH
- PMA / PMN Number
- K020114
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT HAD AN INFECTED KNEE AND THE SURGEON REMOVED THE TIBIA BASEPLATE, TIBIAL INSERT, AND FEMUR. AFTER IRRIGATING THE WOUND, THE SURGEON REIMPLANTED THE FEMUR WHICH HE CLEANSED BEFORE REIMPLANTING AND INSERTED A NEW INSERT. THE SURGEON USED THE INSERT IN A CONSTRUCT WITH ANTIBIOTIC CEMENT. SURGEON BELIEVES THAT A FULL REVISION WILL BE COMPLETED IN ABOUT 3 MONTHS (AFTER THE INFECTION IS GONE). THE PATELLA WAS NOT REMOVED, AS IT WAS KEPT TO COMPLETE THE CONSTRUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3DKNEE | TIBIAL INSERT | HSH | ENCORE MEDICAL, L.P. | 462352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |