SMARTSETGMV ENDURANCE GENT 40G
Received Apr 6, 2026 · Event occurred Mar 18, 2026
Report 1818910-2026-05932 · MDR key 24788867
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Ireland - 3015516266Catalog number
3105040
Lot number
4782800
Product problems
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE SURGERY, IT WAS NOTED THAT THE ENGLISH LABEL INFORMATION DOES NOT MATCH THE ACTUAL PRODUCT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.