UNK_REMOTION IMPLANT

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ORTHOPAEDIC DEPARTMENT, MARTINA HANSENS HOSPITAL. THE TITLE OF THIS REPORT IS LONG-TERM OUTCOMES OF WRIST ARTHROPLASTY USING THE REMOTION IMPLANT IN NON-INFLAMMATORY WRIST PATHOLOGY, PUBLISHED ON MAY 10, 2024, WHICH IS ASSOCIATED WITH THE STRYKER REMOTION IMPLANT SYSTEM. THE ARTICLE CAN BE FOUND ON DOI: 10.1142/S2424835524500218. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT: FOUR PATIENTS EXPERIENCED LOOSENING OF IMPLANT WHICH REQUIRED REVISION. "THIS IS PATIENT 1 OUT OF 4."

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE. THE ARTICLE CAN BE FOUND AT DOI: 10.1142/S2424835524500218. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.