SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

J&J MEDTECH IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH J&J MEDTECH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, J&J MEDTECH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, J&J MEDTECH, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: "JRN COMBO PRODUCTS: DMF# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS." IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

PATIENT WAS REVISED DUE TO INFECTION. CEMENT MANUFACTURER WAS DEPUY SYNTHES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿PATIENT WAS REVISED DUE TO INFECTION." PRODUCT NAME: SMARTSET GHV GENTAMICIN 40G, PRODUCT CODE: 545035500, LOT NUMBER: 4494894, MANUFACTURING DATE: 06-JUN-2024, EXPIRY DATE: 31-MAY-2026, QUANTITY: (B)(4). THERE WERE 2 NON-CONFORMANCES ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PRODUCT NAME: SMARTSET GHV GENTAMICIN 40G, PRODUCT CODE: 545035500, LOT NUMBER: 4494894, MANUFACTURING DATE: 06-JUN-2024, EXPIRY DATE: 31-MAY-2026, QUANTITY: (B)(4). DEVICE HISTORY REVIEW: A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED.