FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR X3 TIBIAL INSERT
MDR report key: 1942435
·
Received December 22, 2010
Report
- Report Number
- 2249697-2010-01877
- Event Type
- Injury
- Date Received
- December 22, 2010
- Date of Event
- November 23, 2010
- Report Date
- December 1, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT: TRIATHLON MIS BASEPLATE #6, CAT# 5520-M-600; LOT SCLTL. TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT, CAT# 5510-F-502; LOT SC63S. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "IT WAS REVISED BECAUSE OF INFECTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | 9Y7MRA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |