UNKNOWN #8 RIGHT ANATO NEUTRAL STEM
Received Mar 16, 2016 · Event occurred Feb 23, 2016
Report 0002249697-2016-00856 · MDR key 5505299
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
67 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT HIP - SWAPPED A #8 RIGHT ANATO NEUTRAL STEM THAT WAS IMPLANTED ON THE LEFT SIDE AND REPLACED WITH AN #8 LEFT ANATO NEUTRAL STEM.
Additional Manufacturer Narrative
CORRECTED DATA: USAGE OF DEVICE. AN EVENT RELATING TO A REVISION SURGERY TO REMOVE A RIGHT SIDE ANATO STEM COMPONENT FROM THE LEFT HIP WAS REPORTED. CONCLUSION: BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED TO REMOVE A RIGHT SIDE ANATO STEM COMPONENT FROM THE LEFT HIP. A LEFT SIDE ANATO STEM COMPONENT WAS SUBSEQUENTLY IMPLANTED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
Description of Event or Problem
IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT HIP - SWAPPED A #8 RIGHT ANATO NEUTRAL STEM THAT WAS IMPLANTED ON THE LEFT SIDE AND REPLACED WITH AN #8 LEFT ANATO NEITRAL STEM.