FDA Adverse Event
Injury
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 1023279
·
Received April 1, 2008
Report
- Report Number
- 1043534-2008-00054
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 5, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. PRODUCT WAS NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO HAVE THE PRODUCT RETURNED FOR EVALUATION. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED. THIS IS THE SAME EVENT AS 1043534-2008-00053.
Description of Event or Problem · 1
ALLEGEDLY PATIENT CALLED SURGEON TO STATE HE WAS HAVING PAIN. X-RAYS SHOW HEAD HAS FRACTURED. A LINER FROM ANOTHER MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR MODULAR FEMORAL NECK | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | U1081491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |