FDA Adverse Event
Other
Summary report: N
FOUNDATION ULTRA-CONGRUENT
MDR report key: 1230278
·
Received November 7, 2008
Report
- Report Number
- 1644408-2008-00407
- Event Type
- Other
- Date Received
- November 7, 2008
- Date of Event
- October 28, 2008
- Report Date
- October 28, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSH
- PMA / PMN Number
- K963028
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE POLY INSERT HAD CONSIDERABLE MEDIAL WEAR FROM COMPONENTS BEING INITIALLY PUT IN VARUS. THE SURGEON MADE SOME LIGAMENT RELEASES AND PUT BACK THE SAME SIZE ULTRA CONGRUENT INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION ULTRA-CONGRUENT | TIBIAL INSERT | HSH | ENCORE MEDICAL, L.P. | 399671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |