inforMED

EXP ACETABULAR SHELL AND LINER

Received Sep 7, 2016 · Event occurred Aug 24, 2016

Report 2530191-2016-00101 · MDR key 5933413

Device

Generic name

36mm Biolox Delta Femoral Head

Manufacturer

Stelkast Inc.

Model number

SC3295-36MM-3.5

Lot number

34703251031

Product problems

  • Device Dislodged or Dislocated
  • Device Dislodged or Dislocated

Patient

69 YR

  • 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 DISLOCATION OF THE HIP.