FDA Adverse Event
Malfunction
Summary report: N
EXETER V40 STEM 44MM NO 0
MDR report key: 2873469
·
Received November 15, 2012
Report
- Report Number
- 9616680-2012-01078
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 22, 2012
- Report Date
- October 23, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS 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
SALES REP REPORTED ON BEHALF OF THE CUSTOMER THAT BOTH CENTRALISER WERE FOUND TO BE MISSING UPON OPENING OF THE PACKAGING. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE COMPLETED WITHOUT ANY DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 44MM NO 0 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | G3303023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |