FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 2831079
·
Received November 2, 2012
Report
- Report Number
- 2249697-2012-02150
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- STRYKER ORHTOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT HAD A TKA 2 WEEKS AGO, PRESENTED TO OFFICE WITH SWOLLEN AND WARM KNEE FOR 2 WEEK FOLLOW UP AT DR K. OFFICE THIS MORNING. PLAN WAS FOR AN EXTENSIVE WASH OUT AND POLY SWAP WHICH WAS PERFORMED WITHOUT DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORHTOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |