inforMED
InjuryMAY

CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM

Received Feb 14, 2018 · Event occurred Jan 31, 2018

Report 2530191-2018-00016 · MDR key 7269502

Device

Generic name

Cross-over 36mm Exp Hooded Liner

Manufacturer

Stelkast Inc.

Model number

SC3474-52

Lot number

34156210109

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

61 YR

  • Unspecified Infection
  • Unspecified Infection

Narrative

Additional Manufacturer Narrative

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS IS A DEVICE RELATED ISSUE.

Description of Event or Problem

PATIENT PRESENTED WITH POSSIBLE SEPSIS. AFTER TREATMENT THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED.