FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 1880678
·
Received October 25, 2010
Report
- Report Number
- 1043534-2010-00420
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- September 8, 2010
- Report Date
- July 8, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K021346
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED BY THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.EVIDENCE THAT PRODUCT IN SPEC WHEN USED.USE OF DEVICE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT. ALLEGEDLY THE PATIENT (ER NURSE) WAS HOLDING A PATIENT DURING A LUMBAR PUNCTURE IN THE ER WHEN THE EVENT OCCURRED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT. ALLEGEDLY THE PATIENT (ER NURSE) WAS HOLDING A PATIENT DURING A LUMBAR PUNCTURE IN THE ER WHEN THE EVENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | 096375520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R |