FDA Adverse Event
Injury
Summary report: N
JAPANESE OMNIFIT EON CS 127 NKSIZE 6 STEM 30 M
MDR report key: 1620551
·
Received February 5, 2010
Report
- Report Number
- 2249697-2009-00987
- Event Type
- Injury
- Date Received
- February 5, 2010
- Date of Event
- January 23, 2008
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- JDI
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 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 6 EVENTS ASSOCIATED WITH THIS EVENT TYPE (USER RELATED AND PRODUCT CODE (JDI).
Description of Event or Problem · 1
USER RELATED. THE DOCTOR UNDERTOOK A THA SURGERY ON (B) (6) 2008, BUT THE SURGEON ASSEMBLED AN EON STEM ((B) (4)) AND AN ALUMINA HEAD ((B) (4)) WITHOUT THE ADAPTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JAPANESE OMNIFIT EON CS 127 NKSIZE 6 STEM 30 M | IMPLANT | JDI | STRYKER ORTHOPAEDICS | NA | JNNMPD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |