PERONAIQ

Description of Event or Problem

ON (B)(6) 2025, I UNDERWENT KNEE REPLACEMENT SURGERY AND CONSENTED ONLY TO A STANDARD MECHANICAL IMPLANT. INSTEAD, WITHOUT MY KNOWLEDGE OR CONSENT, I WAS IMPLANTED WITH A ZIMMER BIOMET PERSONA IQ "SMART KNEE," AN ACTIVE ELECTRONIC DEVICE CONTAINING A LITHIUM-ION BATTERY, SENSORS, AND WIRELESS DATA TRANSMISSION. I WAS NOT INFORMED PRIOR TO SURGERY THAT THE DEVICE WAS ELECTRONIC, WOULD TRANSMIT DATA, OR REQUIRED PRE-OPERATIVE ENROLLMENT AND CONSENT UNDER MANUFACTURER PROTOCOLS, NOR WAS I TOLD I COULD DECLINE IT. I DID NOT ENROLL OR PROVIDE CONSENT, AND THE DEVICE WAS IMPLANTED AND ACTIVATED WHILE I WAS UNDER ANESTHESIA. I ONLY BECAME AWARE AFTER SURGERY WHEN I RECEIVED UNSOLICITED MANUFACTURER COMMUNICATIONS INSTRUCTING ME TO ACTIVATE RELATED SYSTEMS. I HAVE SINCE LEARNED THE DEVICE CONTINUOUSLY TRANSMITS DATA, HAS NO PROVEN CLINICAL BENEFIT PER FDA LABELING, AND INTRODUCES RISKS INCLUDING BATTERY-RELATED HAZARDS, MRI LIMITATIONS, AND CREMATION SAFETY CONCERNS, NONE OF WHICH WERE DISCLOSED. THE DEVICE APPEARS DESIGNED TO GENERATE DATA FOR CORPORATE ANALYTICS AND COMMERCIAL USE WITHOUT PATIENT KNOWLEDGE OR BENEFIT. THIS RAISES SERIOUS CONCERNS REGARDING LACK OF INFORMED CONSENT, CIRCUMVENTION OF REQUIRED ENROLLMENT SAFEGUARDS, FAILURE TO DISCLOSE RISKS, AND POTENTIAL USE OUTSIDE CONDITIONS REQUIRED FOR SAFE AND COMPLIANT USE.