FDA Adverse Event
Injury
Summary report: N
TRIATHLON-CR TIBIAL INSERT #4-11MM
MDR report key: 1891324
·
Received November 2, 2010
Report
- Report Number
- 9610726-2010-00411
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 13, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "REVISED DUE TO SUSPECTED POLY WEAR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-CR TIBIAL INSERT #4-11MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LAZ341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |