4WEB MEDICAL

Description of Event or Problem

IT WAS REPORTED TO THE MANUFACTURER ON 13 JANUARY 2022 THAT A RIGHT ANKLE CUSTOM-MADE DEVICE REVISION WAS PERFORMED ON (B)(6) 2018. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2013 USING A THIRD-PARTY LATERAL PLATE FIXATION. ON (B)(6) 2015, THE SURGEON IDENTIFIED MULTIPLE SCREW FRACTURES. THE PLATE AND SCREW CONSTRUCTS WERE LATER REMOVED IN (B)(6) 2015, FOLLOWING WHICH THE PATIENT WAS NOTED TO BE DOING WELL. ON (B)(6) 2017, A TOTAL KNEE REPLACEMENT WAS IMPLANTED. THE SURGEON NOTED SUBSIDENCE OF THE RIGHT ANKLE CUSTOM-MADE IMPLANT APPROXIMATELY SIX MONTHS LATER, ON (B)(6) 2017. DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2018, THE ORIGINAL CUSTOM-MADE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER 4WEB CUSTOM-MADE DEVICE UTILIZING A THIRD-PARTY INTRAMEDULLARY NAIL AS SUPPLEMENTAL FIXATION.

Additional Manufacturer Narrative

THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THERE WAS NO NON-COMPLIANCE NOTED BY THE SURGEON WITH REGARD TO THE PATIENT FOLLOWING POST-OPERATIVE INSTRUCTIONS. THE PATIENT HAD A HISTORY OF SEVERAL RIGHT ANKLE PROCEDURES PERFORMED PRIOR TO THE ORIGINAL SURGERY WITH 4WEB'S CUSTOM-MADE DEVICE. THE PATIENT ALSO HAD PRE-EXISITING CONDITIONS INCLUDING HIGH BLOOD PRESSURE, DIABETES MELLITUS, AND OSTEOARTHRITIS. THIS INCIDENT WAS IDENTIFIED BY THE MANUFACTURER DURING A RETROSPECTIVE STUDY OF 4WEB CUSTOM-MADE DEVICES IN (B)(6) 2022. NO OTHER COMPLICATIONS HAVE BEEN REPORTED TO THE MANUFACTURER FOLLOWING THE REVISION SURGERY WITH THE NEW CUSTOM-MADE DEVICE.