DEPUY CMW 1 GENTAMICIN BONE CEMENT 40G

Description of Event or Problem

IT WAS REPORTED VOLUNTARY REPORT WAS RECEIVED (MW5185021) IT WAS REPORTED A 55-YEAR-OLD MALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN AND INSTABILITY OF THE JOINT SECONDARY TO LOOSENING OF THE TIBIAL TRAY, AS IDENTIFIED VIA PREOPERATIVE RADIOGRAPHS. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED THE JOINT INSTABILITY AND DEBRIDED SCAR TISSUE. THE TIBIAL TRAT WAS GROSSLY LOOSE AT AN UNKNOWN INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED BUT RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2023. DOR: (B)(6) 2024. 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# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS."