FDA Adverse Event
Injury
Summary report: N
TRIATHLON KNEE SYSTEM
MDR report key: 2680185
·
Received July 30, 2012
Report
- Report Number
- 2249697-2012-01024
- Event Type
- Injury
- Date Received
- July 30, 2012
- Date of Event
- July 17, 2012
- Report Date
- July 17, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THROUGH THE ATTORNEY OF THE PT, AS A RESULT OF A LEGAL CLAIM, THAT "PT ALLEGES DAMAGES AS A RESULT OF IMPLANTATION OF STRYKER ORTHOPAEDICS TRIATHLON KNEE SYSTEM THAT OCCURRED ON (B)(6) 2007."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON KNEE SYSTEM | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |