SMARTSET
Received May 29, 2026 · Event occurred May 1, 2026
Report 1818910-2026-09391 · MDR key 25331210
Device
Generic name
Bone Cement, Antibiotic
Manufacturer
Depuy Cmw - 9610921Catalog number
545035500
Lot number
4942859
Product problems
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN THEY OPENED THE PACKAGE AND THEY FOUND THE ITEM LOOKED LIKE IT EXPLODED INSIDE THE BOX.
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: DMF# - 13704 TRADE NAME ¿ GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS.