PROCARE

Additional Manufacturer Narrative

IT WAS REPORTED THAT ONE WEEK AFTER WEARING THE POST OP SHOE A SPOT UNDER SECOND TOE RIGHT FOOT. I RETURNED TO DR. EXAMINED THE SHOE AND SAW A PIECE OF METAL UNDER THE CUSHION WAS COMING THROUGH AND RUBBING MY FOOT. THE PATIENT IS DIABETIC, SO THE DR STARTED TREATING THE WOUND, AFTER 3 WEEKS HAD GOTTEN LARGER. THE PATIENT RECEIVED TREATMENT FOR ANOTHER 2 MONTHS TRYING TO GET THE WOUND TO HEAL. ON (B)(6) 2023, THE PATIENT WENT SEPTIC FROM THE WOUND ORAL ANTIBIOTICS WHERE NOT WORKING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6), 2023, WHERE AFTER IV ANTIBIOTICS THEY DECIDED TO AMPUTATE THE PATIENTS TOE. THE PATIENT WENT HOME AND WAS READMITTED INTO THE HOSPITAL ON (B)(6)2023, TO REMOVE MORE BONE DUE TO NOT HEALING AT THAT TIME. THE PATIENT WAS SENT HOME THIS TIME WITH A PICC LINE FOR ANTIBIOTICS AND RECEIVED IV ANTIBIOTICS UNTIL (B)(6) 2024. THE DEVICE WAS NOT RETURNED TO ENOVIS FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

Description of Event or Problem

IT WAS REPORTED THAT ONE WEEK AFTER WEARING THE POST OP SHOE A SPOT UNDER SECOND TOE RIGHT FOOT. I RETURNED TO DR. EXAMINED THE SHOE AND SAW A PIECE OF METAL UNDER THE CUSHION WAS COMING THROUGH AND RUBBING MY FOOT. THE PATIENT IS DIABETIC, SO THE DR STARTED TREATING THE WOUND, AFTER 3 WEEKS HAD GOTTEN LARGER. THE PATIENT RECEIVED TREATMENT FOR ANOTHER 2 MONTHS TRYING TO GET THE WOUND TO HEAL. ON (B)(6) 2023, THE PATIENT WENT SEPTIC FROM THE WOUND ORAL ANTIBIOTICS WHERE NOT WORKING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023, WHERE AFTER IV ANTIBIOTICS THEY DECIDED TO AMPUTATE THE PATIENTS TOE. THE PATIENT WENT HOME AND WAS READMITTED INTO THE HOSPITAL ON (B)(6) 2023, TO REMOVE MORE BONE DUE TO NOT HEALING AT THAT TIME. THE PATIENT WAS SENT HOME THIS TIME WITH A PICC LINE FOR ANTIBIOTICS AND RECEIVED IV ANTIBIOTICS UNTIL (B)(6) 2024.