THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.
D
Patient 1
THE MANUFACTURER BECAME AWARE OF A PMCF FROM (B)(6) UNIVERSITY, (B)(6). THE TITLE OF THIS REPORT IS ?2 YEAR FOLLOW UP OF THE MOOVIS PRESS FIT TRAPEZIOMETACARPAL JOINT ARTHROPLASTY? WHICH IS ASSOCIATED WITH THE STRYKER ?MOOVIS? SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM JUNE 2013 TO MARCH 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS 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 24 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PAINFUL EXOSTOSIS FOLLOWED BY REVISION. 3 OUT OF 5 CASES. THE REPORT STATES: ?FIVE PATIENTS DEVELOPED A PAINFUL EXOSTOSIS, AND IN FOUR PATIENTS IT LED TO RE OPERATION WITH REMOVAL OF THE EXOSTOSIS. THE LAST PATIENT DID NOT WANT A RE-OPERATION.?