SMARTSET GHV GENTAMICIN 40G
Received May 29, 2026 · Event occurred May 9, 2026
Report 1818910-2026-09429 · MDR key 25334810
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
3095040
Lot number
4782801
Product problems
- Device Damaged Prior to Receipt by User
Patient
Unknown
- Insufficient Information
Narrative
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. H11: ADDITIONAL MANUFACTURER NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT BEFORE THE SURGERY, WHEN THE PACKAGING OF THE DEVICE WAS OPENED, IT WAS OBSERVED THAT THE AMPOULE WAS BROKEN, AND THE SURGERY WAS STOPPED. IT WAS REPORTED THAT THE DEVICE WAS NOT USED IN THE PROCEDURE. . NO ADDITIONAL INFORMATION COULD BE PROVIDED.