FDA Adverse Event Injury Summary report: N

CMK STEM

MDR report key: 1961940 · Received January 15, 2011

Report

Report Number
8010764-2011-00002
Event Type
Injury
Date Received
January 15, 2011
Date of Event
June 3, 2010
Report Date
January 15, 2010
Manufacturer
SMITH & NEPHEW ORTHOPAEDICS, INC. GERMANY
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

REVISION SURGERY WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CMK STEM CMK21 STEM, 12/14 TAPER 4S1 JDH SMITH & NEPHEW ORTHOPAEDICS, INC. GERMANY 76539426 09MT37667

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R