FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) S ALPHA HIP STEM
MDR report key: 1971248
·
Received January 26, 2011
Report
- Report Number
- 1043534-2011-00027
- Event Type
- Injury
- Date Received
- January 26, 2011
- Date of Event
- December 23, 2010
- Report Date
- December 23, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- PMA / PMN Number
- K041586
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00028.
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. EVIDENCE PRODUCT WAS IN SPEC WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO LOOSENESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) S ALPHA HIP STEM | HIP COMPONENT | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 08474107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |