FDA Adverse Event Summary report: N

GMK PS FEMUR CEMENTED SIZE 2 LEFT

MDR report key: 3140304 · Received May 24, 2013

Report

Report Number
3006639916-2013-00054
Date Received
May 24, 2013
Date of Event
April 22, 2013
Report Date
May 24, 2013
Manufacturer
MEDACTA INTL SA
Product Code
JWH
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
AU
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

FRACTURE OF THE MEDIAL FEMUR CONDYLE DETECTED 1 WEEK POST SURGERY. REF MFR REPORT# 3005180920-2013-00054.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
231140 GMK PS FEMUR CEMENTED SIZE 2 LEFT KNEE FEMUR COMPONENT JWH MEDACTA INTL SA 124192

Patients

Seq Age Sex Outcome Treatment
1 UNK Required Intervention