FDA Adverse Event Injury Summary report: N

SEG TM COLLAR

MDR report key: 2320571 · Received October 26, 2011

Report

Report Number
3005751028-2011-00066
Event Type
Injury
Date Received
October 26, 2011
Date of Event
July 11, 2010
Report Date
October 26, 2011
Manufacturer
ZIMMER TRABECULAR METAL TECHNOLOGY
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT'S WOUND WOULD NOT HEAL, HE EXPERIENCED PAIN AND HAD DIFFICULTY WITH LIMITED MOTION AND AMBULATION. THE PT WAS DIAGNOSED WITH INFECTION, AND THE IMPLANTS WERE REVIEW TO CORRECT THE CONDITION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SEG TM COLLAR TM COLLAR JWH ZIMMER TRABECULAR METAL TECHNOLOGY 61432154

Patients

Seq Age Sex Outcome Treatment
1 86 YR Required Intervention