FDA Adverse Event
Malfunction
Summary report: N
EXETER V40 STEM 35.5 MM
MDR report key: 1629313
·
Received February 5, 2010
Report
- Report Number
- 9610669-2009-00066
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- June 10, 2008
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A.
- Product Code
- JDI
- PMA / PMN Number
- K011623
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION 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 IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (PACKAGE MISSING CONTENTS) AND PRODUCT CODE (JDI).
Description of Event or Problem · 1
PACKAGE MISSING CONTENTS. THE CUSTOMER REPORTED VIA THE SALES REPRESENTATIVE THAT WHEN OPENED, THE PACKAGING DID NOT CONTAIN ANY CENTRALIZERS. IT IS FURTHER REPORTED THAT THE SURGEON IMPLANTED THE STEM WITHOUT USING CENTRALIZERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 35.5 MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A. | NA | G1591556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |