FDA Adverse Event
Summary report: N
FOUNDATION KNEE
MDR report key: 3002276
·
Received March 13, 2013
Report
- Report Number
- 1644408-2013-00153
- Date Received
- March 13, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AFTER FURTHER INVESTIGATION OF THIS COMPLAINT, THERE WERE NO RECORDS FOR THIS PATIENT IN THE DATABASE. THE AGENT INDICATED THAT THE IMPLANT WAS MOST LIKELY FROM A COMPETITOR.
Description of Event or Problem · 1
REVISION SURGERY - DUE TO A POLY SWAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105921 | FOUNDATION KNEE | PRIMARY INSERT 13MM CM | JWH | ENCORE MEDICAL, L.P. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |