UNKNOWN RADIAL STEM
Received Apr 20, 2020 · Event occurred Jan 1, 2007
Report 0008031020-2020-01366 · MDR key 9977860
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. NO PRODUCT IDENTIFICATION IS POSSIBLE. BASED ON THE INVESTIGATION RESULTS, NO DEFINITIVE RELATION COULD BE ESTABLISHED BETWEEN THE PRODUCT AND THE REPORTED FAILURE ADVERSE CONSEQUENCE. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WILL BE PROVIDED. IF FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REEVALUATED AND RESUBMITTED ACCORDINGLY. DEVICE DISPOSITION IS UNKNOWN.
Description of Event or Problem
THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿A-0447 FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF A SINGLE-CENTER SERIES OF 17 WRIST PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿REMOTION¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM 2007-2011. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE/PATIENT DETAIL FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAS NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 7 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO POSTOPERATIVE COMPLICATION. 4 OUT OF 4 CASES. THE REPORT STATES: ¿FOUR PATIENTS HAD POSTOPERATIVE COMPLICATIONS REQUIRING REVISION SURGERY.¿