inforMED

EXP ACETABULAR SHELL AND LINER

Received Sep 21, 2016 · Event occurred Sep 8, 2016

Report 2530191-2016-00104 · MDR key 5966344

Device

Generic name

36mm Biolox Delta Femoral Head

Manufacturer

Stelkast Inc.

Model number

SC3295-36MM +3.5

Lot number

29932-070113

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

Not reported

  • Joint Dislocation
  • Joint Dislocation

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 FOR HIP DISLOCATION.