FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 2901371
·
Received December 14, 2012
Report
- Report Number
- 2249697-2012-02646
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- January 1, 2009
- Report Date
- November 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | MHD2K6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |