FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 1221908
·
Received November 4, 2008
Report
- Report Number
- 2249697-2008-00346
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 9, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "KNEE WAS BEING REVISED SECONDARY TO STIFFNESS. INSERT REMOVED AND YELLOW DISCOLORATION APPRECIATED ON INSERT. PT HISTORY OF PROSTATE CANCER AND LEUKEMIA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | 3L5MHA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |