inforMED

EXP ACETABULAR SHELL AND LINER

Received Nov 3, 2016 · Event occurred Oct 12, 2016

Report 2530191-2016-00134 · MDR key 6076975

Device

Generic name

36mm Cocr Femoral Head

Manufacturer

Stelkast Inc.

Model number

SC3261-36MM -3.5

Lot number

34803251031

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

79 YR

  • Sepsis
  • Sepsis

Narrative

Additional Manufacturer Narrative

AN EVALUATION 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 AFTER TREATMENT FOR INFECTION.