DEPUY CMW 2 GENTAMICIN FAST SET BONE CEMENT 20G

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# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS."

Description of Event or Problem

IT WAS REPORTED THE PATIENTS PRESENTS WITH A LOOSE TIBIAL COMPONENT AT BONE CEMENT INTERFACE VIA XRAY POST TKA. TRAYS IS FOUND WITH CEMENT WELL FIXED TO TRAY HOWEVER THE CEMENT WAS NOT WELL FIXED TO BONE. FEMORAL AND PATELLAR COMPONENTS WERE FOUND TO BE WELL FIXED VIA CEMENT. DEPUY CEMENT WAS USED. A TIBIAL SIDE REVISION WAS PERFORMED WITH NO DELAY NOR PATIENT HARM. THE INSERT WAS EXCHANGED ON (B)(6) 2025. DER 581801 WAS SUBMITTED AT THAT TIME. CEMENT IS HAND MIXED BY THE SURGEON FOR EACH OF HIS CASES. NO STORAGE INFORMATION NOR MIXING TIME IS AVAILABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE REVISION SURGERY OF INSERT ON (B)(6) 2025.