FDA Adverse Event
Malfunction
Summary report: N
TRIATHLON #3 CR INSERT 9MM
MDR report key: 1113312
·
Received August 12, 2008
Report
- Report Number
- 9610726-2008-00051
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K042863
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSERT WAS IMPACTED IN THE CORRECT MANNER WITH THE CORRECT INSTRUMENTATION. THIS LEFT A LARGE HORIZONTAL DEFECT ON THE ANTERIOR ASPECT OF THE INSERT. SURGEON DECIDED TO REPLACE THE INSERT DUE TO THIS DEFECT AS HE WAS CONCERNED ABOUT THE QUALITY OF THE POLY. CLOSER INSPECTION REVEALED PITTING IN THE ARTICULAR SURFACE OF THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON #3 CR INSERT 9MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | H7160LAT834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |