FDA Adverse Event
Injury
Summary report: N
UNKNOWN TIBIAL BASEPLATE
MDR report key: 2911059
·
Received January 4, 2013
Report
- Report Number
- 2249697-2013-90017
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- November 9, 2011
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUBJECT IS ENROLLED IN THE (B)(4) STUDY AND RECEIVED THEIR STUDY SURGERY ON (B)(6) 2011. CRF'S WERE RECEIVED FOR THE STUDY INDICATING THAT THE SUBJECT PRIOR KNEE SYSTEM WAS STRYKER AND WAS REVISED WITH THE TRIATHLON TS KNEE SYSTEM ON (B)(6) 2011. THE SITE NOTED THIS WAS AN ASEPTIC FAILURE OF THE KNEE, TIBIAL LOOSENING AND POLY WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5182 | UNKNOWN TIBIAL BASEPLATE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |