SKELETAL DYNAMICS

Additional Manufacturer Narrative

PER THE INSTRUCTIONS FOR USE: THE FOLLOWING POTENTIAL RISKS OR DISCOMFORTS HAVE BEEN ASSOCIATED WITH CARPOMETACARPAL ARTHROPLASTY: DISASSOCIATION, LOOSENING OR MIGRATION OF THE PROSTHESIS, INFECTION, EROSION AND DEVASCULARIZATION OF THE TRAPEZIUM, MATERIAL SENSITIVITY REACTION, TENDON AND NERVE INJURIES, UNDESIRABLE SHORTENING OR LENGTHENING OF THUMB, STIFFNESS OF THE CMC JOINT, DISLOCATION OR SUBLUXATION DUE TO IMPROPER POSITIONING, WEAR AND DEFORMATION OF THE ARTICULAR SURFACES, INTRAOPERATIVE AND POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN AND INFECTION. THE DEVICE COMPONENT WAS NOT RETURNED FOR EVALUATION AND ALL INVESTIGATIONS WERE BASED ON REPORTED INFORMATION. BASED ON THE INVESTIGATION RESULTS, NO DEFINITIVE RELATION COULD BE ESTABLISHED BETWEEN THE PRODUCT AND THE REPORTED ADVERSE CONSEQUENCE.

Description of Event or Problem

IMPLANT REMOVAL.