MalfunctionMAY
CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM
Received Aug 17, 2017 · Event occurred Jul 21, 2017
Report 2530191-2017-00102 · MDR key 6801152
Device
Generic name
Cross-over Acetabular Shell
Manufacturer
Stelkast Inc.Model number
SC3458-52Lot number
34440250525
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
77 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
INNER RING OF THE CROSS-OVER ACETABULAR SHELL BECAME DISLODGED FROM THE SHELL AFTER IMPACTION. ANOTHER ACETABULAR SHELL OF THE SAME PART NUMBER WAS IMPLANTED SUCCESSFULLY.