FDA Adverse Event
Malfunction
Summary report: N
FOUNDATION KNEE
MDR report key: 2053442
·
Received March 1, 2011
Report
- Report Number
- 1644408-2011-00111
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 22, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K923277
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE SURGEON PERFORMED ALL FUNCTIONAL CUTS, ALL CUTS FIT WITH THE TRIAL, WHEN SURGEON WENT TO PUT THE IMPLANT IN ACROSS THE ENTIRE LATERAL DISTAL SIDE OF THE FEMORAL, THERE WAS A 1MM GAP. THE SURGEON BONE GRAFTED AND USED THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE | NSB FEMORAL POROUS COATED W/NS BEADS | JWH | ENCORE MEDICAL, L.P. | A1000000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | (B)(4), LOT 37825L05 |