MalfunctionMAY
EXP ACETABULAR SHELL AND LINER
Received Sep 8, 2016 · Event occurred Aug 26, 2016
Report 2530191-2016-00103 · MDR key 5936651
Device
Generic name
36mm Id Xlpe Hooded Liner
Manufacturer
Stelkast Inc.Model number
SC3349-36-5860Lot number
35086201207
Product problems
- Difficult or Delayed Positioning
- Difficult or Delayed Positioning
Patient
77 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
AN ANALYSIS 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
SURGEON HAD DIFFICULTY SEATING THE ACETABULAR LINER INTO THE SHELL. ANOTHER LINER FROM THE SAME LOT WAS SUCCESSFULLY IMPLANTED.