FDA Adverse Event Injury Summary report: N

TANDEM

MDR report key: 2893713 · Received January 2, 2013

Report

Report Number
1020279-2013-00010
Event Type
Injury
Date Received
January 2, 2013
Date of Event
December 22, 2012
Report Date
December 27, 2012
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
259 TANDEM FEMORAL COMPONENT JDH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization