SMARTSET GHV GENTAMICIN 40G
Received Jul 14, 2026 · Event occurred Jun 25, 2026
Report 1818910-2026-11953 · MDR key 25818011
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Ireland - 3015516266Catalog number
3095040
Lot number
5134445
Product problems
- Tear, Rip or Hole in Device Packaging
- Difficult to Open or Remove Packaging Material
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO BAGS OF CEMENT HAD ISSUES. IT WAS OBSERVED THAT ONE BAG WAS WELDED TOGETHER WITH THE OUTER BAG. IT WAS FURTHER OBSERVED THAT ONE BAG WAS MISSING AN OUTER BAG SO IT WAS NOT STERILE. IT WAS REPORTED THAT THERE WAS NO DELAY AND NO HARM TO THE PATIENT.
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.