UNKNOWN REMOTION TOTAL WRIST RADIAL IMPLANT
Received Mar 8, 2019 · Event occurred Jan 1, 2009
Report 0008031020-2019-00167 · MDR key 8404504
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Hemolysis
- Hemolysis
Narrative
Additional Manufacturer Narrative
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.
Description of Event or Problem
THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS STUDY IS ¿(B)(6)¿ AND IS ASSOCIATED WITH THE REMOTION TOTAL WRIST SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE CATALOGS FROM THE REPORT; A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION. THEREFORE, 30 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES LYSIS. 10 OUT OF 22 CASES.