Description of Event or Problem · 0
I HAD TOTAL KNEE IMPLANT ON MY LEFT LEG. I HAVE BEEN HAVING PROBLEM WITH IT SINCE DAY ONE. NOW THE BONE SCAN INDICATES THAT THE IMPLANT IS SHOWING THAT IT IS LOSS AND MY DOCTOR IS RECOMMENDING REPLACE THE TOTAL KNEE IMPLANT. MY IMPLANT CATALOG NUMBER IS THE SAME AS IN THIS RECALL LETTER; CLASS 2 DEVICE RECALL TRIATHLON TRITANIUM TIBIAL COMPONENT, SEE RELATED INFORMATION DATE INITIATED BY FIRM MARCH 30, 2022. DATE POSTED JUNE 03, 2022, RECALL STATUS1 OPEN3, CLASSIFIED RECALL NUMBER Z-1237-2022; RECALL EVENT ID 90241 510(K)NUMBER K123486, PRODUCT CLASSIFICATION PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER - PRODUCT CODE JWH PRODUCT TRIATHLON TRITANIUM TIBIAL COMPONENT (SIZE 6); CATALOG NUMBER 5536-B-600, TRIATHLON TRITANIUM TIBIAL COMPONENT (SIZE 5); CATALOG NUMBER 5536-B-500, CODE INFORMATION CATALOG NUMBER UDI-DI (GTIN), LOTS 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106 RECALLING FIRM/ MANUFACTURER HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR, MAHWAH NJ 07430-2006. MANUFACTURER REASON FOR RECALL - STRYKER HAS DISCOVERED A POTENTIAL PRODUCT MIX WHERE THE SIZE OF THE TRIATHLON, TRITANIUM TIBIAL COMPONENT INSIDE THE PACKAGE DOES NOT MATCH THE PACKAGE LABELING. FDA DETERMINED CAUSE 2 UNDER INVESTIGATION BY FIRM ACTION. ON MARCH 30, 2022, THE FIRM SENT URGENT MEDICAL DEVICE RECALL LETTERS TO AFFECTED CUSTOMERS. CUSTOMERS WERE INSTRUCTED TO IMMEDIATELY IDENTIFY, QUARANTINE, AND DISCONTINUE USE OF ANY AFFECTED DEVICES IN THEIR FACILITY. CUSTOMERS SHOULD RETURN THE DEVICES BACK TO STRYKER. IF YOU HAVE ANY QUESTIONS OR CONCERNS REGARDING THIS RECALL, PLEASE CONTACT CUSTOMER SERVICE AT (201) 831-5000. FOR QUESTIONS PERTAINING TO THE RECALL, EMAIL [email protected]. UPDATED 6/6/2022. ON JUNE 6, 2022, THE FIRM SENT AN UPDATED LETTER TO AFFECTED CUSTOMERS. THE UPDATE LETTER INCLUDES THE HAZARDS, HARMS, AND RISK MITIGATION. QUANTITY IN COMMERCE 22 UNITS (12 US; 10 OUS) DISTRIBUTION WORLDWIDE DISTRIBUTION - US NATIONWIDE IN THE STATES OF AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, AND WV. THE COUNTRIES OF UK AND POLAND. TOTAL PRODUCT LIFE CYCLE TPLC(TOTAL PRODUCT LIFE CYCLE) DEVICE REPORT. I HAVE MY OPERATIVE REPORTS FROM THE HOSPITAL, AND MY DOCTOR WAS INDICATE THAT THIS IMPLANT WAS INSTALLED. I HAVE BEEN SCHEDULED FOR A REVISION SURGERY FOR (B)(6), 2023. REF REPORT: MW5149273.