ZIMMER TRABECULAR METAL PATELLA, SINGLE PEG

Description of Event or Problem

THE ZIMMER PATELLA IMPLANT WAS IMPLANTED WITH A CONFORMIS IDUO G2 BICOMPARTMENTAL KNEE IMPLANT. FRACTURE OF THE PATELLA IMPLANT WAS REPORTED. REVISION SURGERY OCCURRED TO REMOVE THE PATELLA IMPLANT. A PARTIAL PATELLECTOMY WAS PERFORMED.

Additional Manufacturer Narrative

CONFORMIS CLINICAL AFFAIRS DEPARTMENT RECEIVED A REPORT THAT A STUDY PATIENT WITH AN IDUO G2 IMPLANT REQUIRED SURGICAL INTERVENTION TO REMOVE A FRACTURED PATELLA IMPLANT. THE PATELLA IMPLANT THAT WAS IMPLANTED WITH THE IDUO G2 DEVICE WAS NOT MANUFACTURED BY CONFORMIS. THE IMPLANTED CONFORMIS IDUO G2 DEVICE DOES NOT APPEAR TO BE RELATED TO THIS ADVERSE EVENT. EVENT DESCRIPTION IS PROVIDED IN THE ATTACHED REPORT.