InjuryMAY
EXP ACETABULAR SHELL AND LINER
Received Feb 14, 2018 · Event occurred Jan 31, 2018
Report 2530191-2018-00015 · MDR key 7269507
Device
Generic name
36mm Biolox Head
Manufacturer
Stelkast Inc.Model number
SC3295-36MM +0Lot number
35087260123
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.