FDA Adverse Event Injury Summary report: N

SL PLUS MIA STEM

MDR report key: 2770048 · Received October 3, 2012

Report

Report Number
9613369-2012-00084
Event Type
Injury
Date Received
October 3, 2012
Date of Event
April 5, 2010
Report Date
September 5, 2012
Manufacturer
SMITH&NEPHEW -SWITZERLAND
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SL PLUS MIA STEM FEMORAL COMPONENT JDH SMITH&NEPHEW -SWITZERLAND

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R