DEPUY CMW 1G 20G
Received Apr 29, 2026 · Event occurred Apr 9, 2026
Report 1818910-2026-07776 · MDR key 25028832
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Cmw - 9610921Catalog number
3315020
Lot number
4939399
Product problems
- Chemical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER MIXING THE BONE CEMENT UNDER VACUUM AT ROOM TEMPERATURE (APPROXIMATELY 18°C), THE CEMENT BECAME VERY FIRM AND HARDENED AFTER FIVE MINUTES. THE CEMENT WAS ALREADY HARD WHEN DISPENSED FROM THE NOZZLE AT ABOUT ONE MINUTE, AND BY ONE AND A HALF MINUTES, IT WAS TOO HARD TO APPLY TO THE FEMUR, LEADING TO CESSATION OF USE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.
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.