inforMED
InjuryMAY

CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM

Received Mar 6, 2018 · Event occurred Feb 8, 2018

Report 2530191-2018-00030 · MDR key 7317834

Device

Generic name

Cross Over Shell

Manufacturer

Stelkast Inc.

Model number

SC3458-52

Lot number

38853270409

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

65 YR

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

PATIENT PRESENTED FOR HIP SURGERY FOR UNKNOWN REASON. DURING THIS SURGERY, THE SURGEON USED A 36MM LINER INSERTER TO INSERT AN ACETABULAR LINER INTO THE SHELL. DURING IMPACTION, IT WAS STATED THAT THE LINER WOULD NOT SEAT PROPERLY. WHILE EXTRACTING THE LINER WITH A HEMOSTAT, THE SURGEON NOTED THAT THE LOCKING RING DETACHED FROM THE ACETABULAR SHELL. THE LOCKING RING WAS REINSERTED AND USING A 32MM LINER INSERTER HE WAS ABLE TO SEAT THE ORIGINAL LINER PROPERLY.