FDA Adverse Event Injury Summary report: N

UNKNOWN ZIMMER KNEE

MDR report key: 2133633 · Received June 16, 2011

Report

Report Number
1822565-2011-01430
Event Type
Injury
Date Received
June 16, 2011
Report Date
May 20, 2011
Manufacturer
ZIMMER, INC.
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 OSTEOLYSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN ZIMMER KNEE KNEE PROSTHESIS JWH ZIMMER, INC.

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention