FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 1061651
·
Received June 17, 2008
Report
- Report Number
- 9610726-2008-00036
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- April 18, 2006
- Report Date
- February 11, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HSH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT PRESENTED WITH A SORE RIGHT TOTAL KNEE ARTHROPLASTY (RTKA). X-RAYS SHOWED RADIOLUCENT LINES AROUND FEMUR AND TIBIA. REVISION RTKA WAS PRESCRIBED. IN 2008, REVISION WAS PERFORMED. SEVERE PITTING OF THE X3 TIBIA INSERT WAS OBVIOUS. SLIGHT DISCOLORATION WAS ALSO OBVIOUS ON BOTH THE ARTICULATING SIDE AND BACKSIDE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | HSH | STRYKER ORTHOPAEDICS LIMERICK | NA | 37593401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |