inforMED
InjuryMAY

EXP ACETABULAR SHELL AND LINER

Received Jan 21, 2019 · Event occurred Aug 1, 2018

Report 2530191-2019-00002 · MDR key 8264276

Device

Generic name

32mm Id Xlpe Hooded Liuner

Manufacturer

Stelkast Inc.

Model number

SC3345-32-5052

Lot number

30925-012714

Product problems

  • Material Fragmentation
  • Material Fragmentation

Patient

Not reported

  • Joint Dislocation
  • Joint Dislocation

Narrative

Additional Manufacturer Narrative

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

STELKAST WAS MADE AWARE OF A REVISION SURGERY THAT REQUIRED RE-IMPLANTATION OF A REPLACEMENT PROSTHETIC HIP.