FDA Adverse Event
Injury
Summary report: N
PROFEMUR Z STEM PLASMA SPRAYED
MDR report key: 1030106
·
Received April 14, 2008
Report
- Report Number
- 1043534-2008-00064
- Event Type
- Injury
- Date Received
- April 14, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 22, 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. PROD NOT RETURNED FOR EVAL. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS IS THE SAME EVENT AS 1043534-2008-00063, 00065, 00066.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO THE REVISION OF A RELATED PROSTHESIS (NECK).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR Z STEM PLASMA SPRAYED | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | U0366119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |