FDA Adverse Event
Injury
Summary report: N
ASCEND HIGH OFFSET HUMERAL HEAD
MDR report key: 3161774
·
Received June 6, 2013
Report
- Report Number
- 3004983210-2013-00018
- Event Type
- Injury
- Date Received
- June 6, 2013
- Date of Event
- April 30, 2013
- Report Date
- May 7, 2013
- Manufacturer
- TORNIER INC
- Product Code
- KWT
- PMA / PMN Number
- K071147
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
POST OP, SEPSIS, TREATED WITH RESECTION ARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249675 | ASCEND HIGH OFFSET HUMERAL HEAD | NONE | KWT | TORNIER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |