UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT
Received Mar 8, 2019 · Event occurred Jan 1, 2009
Report 0008031020-2019-00173 · MDR key 8404616
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
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 (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 REVISION DUE TO OSTEOLYSIS. 3 OUT OF 5 CASES.