FDA Adverse Event
Other
Summary report: N
UNK TRIATHLON TS KNEE SYSTEM
MDR report key: 1695392
·
Received May 18, 2010
Report
- Report Number
- 2249697-2010-00554
- Event Type
- Other
- Date Received
- May 18, 2010
- Date of Event
- April 29, 2008
- Report Date
- April 29, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE IS NOT AVAILABLE DUE TO THE ONGOING LITIGATION. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT HAD A TRIATHLON TS KNEE SYSTEM IMPLANTED ON (B)(6), 2008." IT WAS FURTHER REPORTED THAT, "AS A RESULT THE PATIENT BEGAN EXPERIENCING DIFFICULTIES. THE PATIENT HAS INCURRED MEDICAL EXPENSES, LOST WAGES..ETC."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK TRIATHLON TS KNEE SYSTEM | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |