SMARTSET GMV 40G US EO
Received Dec 17, 2025 · Event occurred Dec 1, 2025
Report 1818910-2025-22048 · MDR key 23826920
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Cmw - 9610921Catalog number
545050501
Lot number
4682725
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
89 YR · Male
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE DEPUY SYNTHES (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 545050501, LOT - 4682725) COMBINATION. 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- A SEARCH OF THE DEPUY SYNTHES (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 545050501, LOT - 4682725) COMBINATION. H11 ADDITIONAL NARRATIVE: ADDED: B5, D10 (CONCOMITANT). CORRECTED: D3, G1 (MANUFACTURING SITE NAME).
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE MANUFACTURER OF THE 1ST LINER? IS IT FROM DEPUY? - YES.
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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER NARRATIVE: G4: 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 THAT THE PATIENT WAS REVISED WITH SECOND LINER EXCHANGE TO RULE OUT INFECTION. AFFECTED SIDE: RIGHT KNEE.