KeriFlex MCP and PIP Finger Joint Prosthesis

Description of Event or Problem

It was reported that a patient underwent a joint arthroplasty. Subsequently, the patient underwent revision surgery, due to material fatigue. Symptoms secondary to silicone prosthesis fracture; moderate synovitis associated with silicone wear debris; no evidence of infection.

Additional Manufacturer Narrative

Based on the available evidence. the implant appears to be positioned in the interphalangeal joint of the thumb. As per the IFU, KeriFlex® - MCP & PIP Finger Joint Implants are intended to replace pathologically altered MCP and PIP joints. The thumb does not have a PIP joint; it has a single interphalangeal (IP) joint. This case is considered as an abnormal use of the implant.