FDA Adverse Event Injury Summary report: N

QUADRA H FEMORAL STEM SIZE 3 LATERALIZED

MDR report key: 4143547 · Received September 5, 2014

Report

Report Number
3006639916-2014-00115
Event Type
Injury
Date Received
September 5, 2014
Date of Event
August 6, 2014
Report Date
September 5, 2014
Manufacturer
MEDACTA INTERNATIONAL SA
Product Code
KWY
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
SZ
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

REVISION SURGERY DUE TO A PERIPROSTHETIC FEMORAL FRACTURE. MFR REF# 3005180920-2014-00115.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
544466 QUADRA H FEMORAL STEM SIZE 3 LATERALIZED FEMORAL CEMENTLESS STEM LAT KWY MEDACTA INTERNATIONAL SA 072255

Patients

Seq Age Sex Outcome Treatment
1 UNK Required Intervention