FDA Adverse Event
Injury
Summary report: N
SCORPIO TS FEM W/LFIT
MDR report key: 2540731
·
Received February 5, 2010
Report
- Report Number
- 2249697-2010-01954
- Event Type
- Injury
- Date Received
- February 5, 2010
- Date of Event
- December 13, 2005
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- JWH
- PMA / PMN Number
- K994128
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYS IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B)(4) 2006 TO (B)(4) 2008, WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION #(B)(4). THERE ARE 12 EVENTS ASSOCIATED WITH THIS EVENT TYPE (POST-OPERATIVE ADVERSE EVENT) AND PRODUCT CODE (JWH).
Description of Event or Problem · 1
POST OPERATIVE ADVERSE RESULT. PERSISTING INFECTION, WOUND DEHISCENCE, PATELLA TENDON PLASTY, COVERAGE WITH GASTROCNEMIUS PLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO TS FEM W/LFIT | IMPLANT | JWH | STRYKER ORTHOPAEDICS | NA | K05N98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |