FDA Adverse Event
Injury
Summary report: N
PROFEMUR Z STEM PLASMA SPRAYED
MDR report key: 1222519
·
Received November 6, 2008
Report
- Report Number
- 1043534-2008-00319
- Event Type
- Injury
- Date Received
- November 6, 2008
- Date of Event
- October 21, 2008
- Report Date
- October 21, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K021346
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ATTEMPTS ARE BEING MADE TO HAVE THE IMPLANT RETURNED FOR EVALUATION. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00318.
Description of Event or Problem · 1
ALLEGEDLY REMOVED STEM DURING REVISION OF NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR Z STEM PLASMA SPRAYED | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 056334875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| R |