UNKNOWN CARPAL BALL
Received Apr 20, 2020 · Event occurred Jan 1, 2007
Report 0008031020-2020-01363 · MDR key 9977684
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. 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.
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 TO WRIST ARTHRODESIS. 1 OUT OF 3 CASES. THE REPORT STATES: ¿WRIST ARTHRODESIS WAS PERFORMED IN THREE PATIENTS.¿