Description of Event or Problem · 0
PATIENT PRESENTED ON [REDACTED DATE] FOR RIGHT TOTAL KNEE REPLACEMENT W/ CUSTOM IMPLANT. DURING PROCEDURE, SURGEON USED CUSTOM KNEE IMPLANT PROVIDED BY RESTOR3D THAT INCLUDED METALLIC FEMORAL AND TIBIAL IMPLANTS, AND POLYMER IMPLANTS AND INSTRUMENTATION. PROCEDURE PROGRESSED, AND THE FINAL IMPLANTS WERE OPENED AND CEMENTED INTO PLACE WITH TOBRAMYCIN LOADED CEMENT. SURGEON THEN INFORMED BY OR STAFF THAT THERE WAS A QUESTION OF STERILITY OF THE FINAL FEMORAL AND TIBIAL COMPONENTS, AFTER A RE-REVIEW OF PACKAGING. THE CUSTOM IMPLANT ARRIVED IN TYVEK PACKAGING THAT WAS CONSISTENT WITH STERILIZATION, AND CONSISTENT WITH ALL OTHER PARTS OF THE CUSTOMIZED IMPLANT SET THAT HAD BEEN STERILIZED AND PACKAGED SIMILARLY IN TYVEK AND LABELED AS STERILE. ON REVIEW OF THE CUSTOM IMPLANT LABEL, THERE WAS A STICKER WITH THE WORDS ¿NOT STERILE¿, WHICH WAS ADJACENT TO THE WORDS ¿IF PACKAGE IS COMPROMISED¿. THEREFORE, IT WAS NOT CLEAR TO OR STAFF IF THE CUSTOM IMPLANT WAS STERILE OR NOT. A REPRESENTATIVE FROM THE MANUFACTURER WAS PRESENT IN THE OR. THE REPRESENTATIVE WAS UNABLE TO CONFIRM STERILITY AT THAT TIME AND WAS NOT ABLE TO SPEAK TO THE PACKAGING. AS THE CUSTOM IMPLANT HAD ALREADY BEEN CEMENTED, THE SURGEON CONDUCED A RISK/ BENEFIT ANALYSIS AND MADE THE DECISION TO LEAVE IMPLANT IN PLACE. INFECTIOUS DISEASE WAS IMMEDIATELY CONSULTED, AND THE PATIENT WAS STARTED ON BROAD SPECTRUM ANTIBIOTICS. ADDITIONAL FOLLOW UP WITH THE COMPANY OCCURRED, CONFIRMING THE CUSTOM IMPLANT WAS IN FACT NOT STERILE. MANUFACTURER RESPONSE FOR CUSTOM KNEE IMPLANT, RESTOR3D (PER SITE REPORTER) WE WERE IMMEDIATELY IN CONTACT WITH THE MANUFACTURER TO DISCUSS. IT IS OUR UNDERSTANDING THAT THE MANUFACTURER HAS IMPLEMENTED THE FOLLOWING CHANGES: NON-STERILE DEVICES WILL NO LONGER BE PROVIDED IN TYVEK PACKAGING. NON-STERILE ITEMS WILL ONLY BE PROVIDED IN POLYBAGS. EACH NON-STERILE COMPONENT WILL BE IN DOUBLE POLYBAG, WHICH WILL BE PLACED WITHIN AN ADDITIONAL OUTER POLYBAG. NON-STERILE DEVICES WILL NOT BE PLACED WITHIN THE OUTER BOX AND WILL ARRIVE IN AN OUTER POLYBAG. IT IS OUR UNDERSTANDING THAT LABEL CONTENTS ARE NOT CHANGING. NON-STERILE INDICATORS WILL REMAIN THE SAME.