InjuryMAY
EXP ACETABULAR SHELL AND LINER
Received Apr 11, 2018 · Event occurred Mar 29, 2018
Report 2530191-2018-00039 · MDR key 7420941
Device
Generic name
32mm Biolox Delta Femoral Head
Manufacturer
Stelkast Inc.Model number
SC3348-32MM +3.5Lot number
34981260219
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
43 YR
- Joint Dislocation
- Joint Dislocation
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 A DEVICE MALFUNCTION HAD OCCURRED.
Description of Event or Problem
PATIENT PRESENTED FOR SURGERY FOR HIP DISLOCATION. FEMORAL HEAD REVISED.