CONSERVE® CEMENTLESS FEMORAL COMPONENT 46MM

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, PATIENT AT 8 YEARS 8 MONTHS POST-IMPLANTATION, STATED VIA E-MAIL THAT HE HAS BLOOD COBALT OF 27 NMOL/L (35% ABOVE NORMAL) AND URINE COBALT OF 175 NMOL/L (9× BLOOD) FACING POTENTIAL REVISION SURGERY. THE REPORTER HAS NOT PROVIDED ANY SUBSTANTIAL MEDICAL INFORMATION OR LEGAL ASSESSMENT THAT SERVES AS EVIDENCE TO CONFIRM ANY DEFICIENCIES AGAINST THE DEVICES DESPITE OF SEVERAL REQUESTS FOR ADDITIONAL INFORMATION. CASE REFERRED TO THE LEGAL DEPARTMENT FOR FOLLOW-UP. ADDITIONAL INFORMATION RECEIVED ON 06/10/2026: ALLEGEDLY, ON (B)(6) 2016, THEIR OR SUPPLY MANAGER EMAILED STAFF CONFIRMING: JUST AN FYI AS YOU KNOW WE HAVE ALREADY SWAPPED OUT AND RETURNED ALL OF THE AFFECTED PRODUCT. DESPITE THIS WRITTEN CONFIRMATION OF COMPLIANCE, (B)(6) CAMPUS LEFT THE 2013-MANUFACTURED STOCK (MANUFACTURED APRIL 30,2013) IN INVENTORY AND IMPLANTED THE 38BF4652 CONSERVE BIOFOAM CUP INTO ME ON (B)(6) 2017, 11 MONTHS AFTER THEY CLAIMED THE PRODUCT HAD BEEN REMOVED. RESULTING INJURIES: THEMODULAR TAPER-JUNCTION DESIGN CAUSED METALLOSIS, ELEVATED COBALT AND CHROMIUM ION LEVELS, SEVERE TISSUE DAMAGE, PAIN, FOOT DROP, AND OTHER COMPLICATIONS REQUIRING ONGOING MEDICAL CARE AND MONITORING.? HEALTH CANADA FILE: (B)(4).