FDA Adverse Event Injury Summary report: N

NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

MDR report key: 4142789 · Received September 23, 2014

Report

Report Number
3007963827-2014-00048
Event Type
Injury
Date Received
September 23, 2014
Date of Event
November 20, 2013
Report Date
August 25, 2014
Manufacturer
ZIMMER ORTHOPEDIC MFG LTD
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
590956 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 61527826

Patients

Seq Age Sex Outcome Treatment
1 56 YR Required Intervention