inforMED

EXP ACETABULAR SHELL AND LINER

Received Aug 9, 2016 · Event occurred Jul 18, 2016

Report 2530191-2016-00088 · MDR key 5857787

Device

Generic name

36mm Xlpe Hooded Liner

Manufacturer

Stelkast Inc.

Model number

SC3349-36-5456

Lot number

31915-080714

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

82 YR

  • No Code Available
  • No Code Available

Narrative

Additional Manufacturer Narrative

AN ANALYSIS OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PATIENT REVISED DUE TO UNSTABLE THA.