inforMED
InjuryMAY

EXP ACETABULAR SHELL AND LINER

Received Nov 30, 2016 · Event occurred Nov 14, 2016

Report 2530191-2016-00149 · MDR key 6134882

Device

Generic name

36mm Cocr Femoral Head

Manufacturer

Stelkast Inc.

Model number

SC3261-36MM -3.5

Lot number

35917260503

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

81 YR

  • Unspecified Infection
  • Unspecified Infection

Narrative

Additional Manufacturer Narrative

AN EVALUATION 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

ACETABULAR LINER AND FEMORAL HEAD REVISED AFTER TREATMENT FOR INFECTION IN THE HIP.