FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 2761309
·
Received September 26, 2012
Report
- Report Number
- 1043534-2012-01223
- Event Type
- Injury
- Date Received
- September 26, 2012
- Date of Event
- September 20, 2011
- Report Date
- September 11, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN/THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED/
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01222, 01224. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY IN (B)(6) 2011 THERE WAS PAIN. ALVAL. STEM WAS NOT REVISED. MEDIUM ACTIVITY LEVEL. NO TRAUMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT, CODE:LWJ | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | 0901204273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |