inforMED
InjuryMAY

EXP ACETABULAR SHELL AND LINER

Received Apr 12, 2017 · Event occurred Mar 28, 2017

Report 2530191-2017-00062 · MDR key 6485414

Device

Generic name

32mm Biolox Delta Femoral Head

Manufacturer

Stelkast Inc.

Model number

SC3348-32MM -3.5

Lot number

32778-102814

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

63 YR

  • No Code Available
  • No Code Available

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

PATIENT REVISED DUE TO HIP INSTABILITY.