FDA Adverse Event
Malfunction
Summary report: N
EXETER V40 STEM 37.5MM NO 0
MDR report key: 2885288
·
Received November 21, 2012
Report
- Report Number
- 9616680-2012-01160
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 30, 2012
- Report Date
- October 30, 2012
- Manufacturer
- STRYKERORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K011623
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE SALES REP REPORTED ON BEHALF OF THE CUSTOMER THAT IT WAS NOTICED THAT THERE WERE TOW WINGLESS CENTRALIZERS INSTEAD OF 1 X WINGED AND 1 X WINGLESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 37.5MM NO 0 | IMPLANT | JDI | STRYKERORTHOPAEDICS CORK | NA | G3277481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |