SMARTSET GMV 40G US EO

Description of Event or Problem

IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. TIBIAL IMPLANT WAS POSITIONED WITH A SLIGHT ANTERIOR SLOPE. TIBIA DEBONDED AT THE CEMENT/IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED. FEMUR WAS NOT LOOSE. NO DELAYS OR PT INJURY. DOI: (B)(6) 2014. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. "JRN COMBO PRODUCTS: DMF# (B)(4). TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS."