FDA Adverse Event
Injury
Summary report: N
UNKNOWN_SCORPIO TIBIAL POLY
MDR report key: 5769725
·
Received July 5, 2016
Report
- Report Number
- 0002249697-2016-02180
- Event Type
- Injury
- Date Received
- July 5, 2016
- Date of Event
- January 3, 2016
- Report Date
- June 9, 2016
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS REPORTED VIA CLINICAL OUTCOMES REPORTING STUDIES. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
PATIENT HAD AN INDEX SURGERY OUTSIDE RI. ON (B)(6) 2015 DR. (B)(6) REVISED THE PATIENT FOR DJI WITH EXCHANGE OF THE POLY ONLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422781 | UNKNOWN_SCORPIO TIBIAL POLY | KNEE IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |