FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 4243394
·
Received November 11, 2014
Report
- Report Number
- 0002249697-2014-04235
- Event Type
- Injury
- Date Received
- November 11, 2014
- Date of Event
- October 17, 2014
- Report Date
- October 17, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K910990
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS A (B)(4), SERIES 7000 CEMENTLESS TIBIAL COMPONENT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
A 2014 (B)(4) SUPPLEMENTARY REPORT IDENTIFIED THE SCORPIO NRG CEMENTLESS/ SERIES 7000 CEMENTLESS TOTAL KNEE REPLACEMENT COMBINATION AS HAVING A HIGHER THAN ANTICIPATED REVISION RATE COMPARED WITH ALL OTHER TOTAL KNEE PROSTHESES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725666 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |