FDA Adverse Event Injury Summary report: N

UNKNOWN NEXGEN CR-FLEX KNEE

MDR report key: 3954780 · Received July 18, 2014

Report

Report Number
1822565-2014-00887
Event Type
Injury
Date Received
July 18, 2014
Date of Event
February 26, 2010
Report Date
June 20, 2014
Manufacturer
ZIMMER INC
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
422538 UNKNOWN NEXGEN CR-FLEX KNEE KNEE PROSTHESIS JWH ZIMMER INC

Patients

Seq Age Sex Outcome Treatment
1 69 YR Required Intervention