FDA Adverse Event
Injury
Summary report: N
EXETER V40 STEM 37.5MM NO 1
MDR report key: 1620553
·
Received February 5, 2010
Report
- Report Number
- 9610669-2009-00063
- Event Type
- Injury
- Date Received
- February 5, 2010
- Date of Event
- July 17, 2006
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A.
- Product Code
- KWY
- PMA / PMN Number
- K011623
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, (B) (4) CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO (B) (4) 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 11 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DAMAGED STERILE PACKAGE) AND PRODUCT CODE (JDI).
Description of Event or Problem · 1
DAMAGED STERILE PACKAGE. IT WAS REPORTED "OPENED PACKAGE TO STERILE FILED NOTICED HOLE IN PACKAGE, DETERMINED STERILITY NOT COMPROMISED, SO WE USED STEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 37.5MM NO 1 | IMPLANT | KWY | STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A. | NA | G1172515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |