STRYKER HIGH VISCOSITY BONE CEMENT

Description of Event or Problem

STRYKER HV CEMENT WAS USED IN THIS PATIENTS KNEE REPLACEMENT WHICH FAILED PREMATURELY AND HAD TO BE REVISED. THE FINDINGS AT SURGERY WERE CONSISTENT WITH FAILURE OF THE CEMENT PRODUCT TO BOND TO THE IMPLANTS. THIS RESULTED IN A FAILURE OF THE KNEE REPLACEMENT WHICH NECESSITATED FURTHER SURGERY. ORIGINAL SURGERY WAS (B)(6) 2017. PAIN AND SWELLING STARTED ABOUT ONE YEAR POST SURGERY. WORK UP WAS CLASSIC FOR HV CEMENT FAILURE AS I HAVE SEEN ABOUT 50 PATIENTS WITH THIS PROBLEM. I AM JUST STARTING TO REPORT MY CASES AT THIS TIME. AS FAR AS I AM AWARE I MAY HAVE USED THIS PRODUCT ON APPROXIMATELY 350 PATIENTS OVER A TIME FRAME OF ABOUT 3 YEARS. I AM PREDICTING THE FAILURE RATE FOR THIS PRODUCT TO APPROACH 15- 20%- IN A TIME FRAME OF ONLY ABOUT 1.5-2.5 YEARS. THE FAILURE RATE SHOULD BE ABOUT 1% PER YEAR. FDA SAFETY REPORT ID# (B)(4).