FDA Adverse Event Injury Summary report: N

UNK PHK ARTICULAR SURFACE

MDR report key: 4317094 · Received December 4, 2014

Report

Report Number
1822565-2014-01691
Event Type
Injury
Date Received
December 4, 2014
Date of Event
October 29, 2014
Report Date
November 5, 2014
Manufacturer
ZIMMER, INC.
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
PHYSICIAN

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 PT WAS REVISED DUE TO MIGRATION OF THE ARTICULAR SURFACE HINGE PIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
784644 UNK PHK ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC.

Patients

Seq Age Sex Outcome Treatment
1 62 YR Required Intervention