KERIFLEX MCP AND PIP FINGER JOINT PROSTHESIS

Additional Manufacturer Narrative

THE INVESTIGATION RELATED TO THIS EVENT IS ONGOING. AT THIS TIME, THE AVAILABLE INFORMATION IS INSUFFICIENT TO DETERMINE A DEFINITIVE ROOT CAUSE OR WHETHER THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. A SUPPLEMENTAL MDR WILL BE SUBMITTED TO FDA UPON COMPLETION OF THE INVESTIGATION AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT ARTHROPLASTY OF KERIFLEX PROSTHESIS. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT BREAKAGE. THE PATIENT REPORTED PAIN AND LIMITED MOVEMENT.