Description of Event or Problem · 0
THIS REPORT CONCERNS A SUSPECTED MECHANICAL FAILURE OF THE BIOPRO MODULAR THUMB IMPLANT (CMC (CARPOMETACARPAL) JOINT) IMPLANTED IN MY LEFT THUMB ON (B)(6) 2024. THE IMPLANT HAS DEVELOPED PERMANENT DISLOCATION OF THE BALL COMPONENT FROM THE TRAPEZIUM SOCKET, ASSOCIATED WITH PROGRESSIVE WEAR OF THE TRAPEZIUM THAT OCCURRED DURING POSTOPERATIVE MODELING AND USE. THE DEVICE NO LONGER MAINTAINS ARTICULATION WITHIN THE INTENDED SOCKET, RESULTING IN PERSISTENT INSTABILITY AND PAIN. CLINICAL COURSE: AFTER A PERIOD OF INITIAL FUNCTION WITH PAIN, I DEVELOPED INCREASING CMC JOINT PAIN, MECHANICAL INSTABILITY, AND LOSS OF FUNCTIONAL PINCH STRENGTH. OVER TIME, THE BALL COMPONENT BEGAN TO DISLOCATE FROM THE TRAPEZIUM SOCKET, AND THIS PROGRESSED TO A FIXED, NON-MAINTAINABLE DISLOCATION. CONSERVATIVE MEASURES (SPLINTING, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, INJECTIONS, ACTIVITY MODIFICATION) DID NOT RESTORE STABILITY OR REDUCE SYMPTOMS. OBJECTIVE FINDINGS: PHYSICAL EXAM DEMONSTRATES PERSISTENT DORSAL¿RADIAL DISLOCATION OF THE BALL COMPONENT RELATIVE TO THE TRAPEZIUM SOCKET. THE BALL CAN BE MANUALLY REDUCED EXTERNALLY BUT IMMEDIATELY DISLOCATES DUE TO INABILITY OF THE WORN TRAPEZIUM TO CUP OR RETAIN THE BALL. CIRCUMDUCTION AND AXIAL LOADING REPRODUCE MECHANICAL INSTABILITY AND PAIN. IMAGING SHOWS TRAPEZIAL WEAR, SOCKET EROSION, COMPONENT MALALIGNMENT, LOSS OF CONTAINMENT. NO SIGNS OF INFECTION; SYMPTOMS AND IMAGING ARE CONSISTENT WITH MECHANICAL FAILURE OF THE IMPLANT¿BONE INTERFACE. DEVICE PERFORMANCE CONCERN: THE FAILURE MODE APPEARS TO BE PROGRESSIVE TRAPEZIUM WEAR LEADING TO LOSS OF SOCKET INTEGRITY, RESULTING IN INABILITY OF THE TRAPEZIUM TO RETAIN THE BALL COMPONENT. THIS HAS PRODUCED IRREDUCIBLE FUNCTIONAL DISLOCATION AND LOSS OF IMPLANT STABILITY. THE DEVICE IS NO LONGER CAPABLE OF PERFORMING ITS INTENDED FUNCTION AS A STABLE CMC JOINT ARTHROPLASTY. INTERVENTION AND OUTCOME: REVISION SURGERY IS PLANNED BUT DATE NOT SET. THE IMPLANT FAILURE HAS RESULTED IN SIGNIFICANT PAIN, MECHANICAL DYSFUNCTION, AND IMPAIRMENT OF DAILY ACTIVITIES REQUIRING PINCH OR GRASP OR EVEN WITHOUT MOVEMENT. I AM SUBMITTING THIS VOLUNTARY REPORT TO NOTIFY THE FOOD AND DRUG ADMINISTRATION OF A POTENTIAL DEVICE MALFUNCTION AND CLINICALLY SIGNIFICANT FAILURE MODE. DEVICE INFORMATION: DEVICE: BIOPRO MODULAR THUMB IMPLANT (CMC); MANUFACTURER: BIOPRO, INC.; IMPLANT DATE: (B)(6) 2025; LOT/SERIAL NUMBER: UNKNOWN; IMPLANT LOCATION: LEFT THUMB CMC JOINT REPORTER INFORMATION: I AM THE PATIENT SUBMITTING THIS VOLUNTARY REPORT. MY SURGEON PRACTICES IN A PRIVATE CLINICAL SETTING AND IS NOT A MANDATORY REPORTER UNDER FDA DEVICE SURVEILLANCE REGULATIONS. SHOWED DISLOCATION OF THE IMPLANT.