SMARTSET GHV GENTAMICIN 40G
Received May 8, 2026 · Event occurred Apr 10, 2026
Report 1818910-2026-08504 · MDR key 25125692
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Cmw - 9610921Catalog number
3095040
Lot number
4618008
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Dyspnea
- Tachycardia
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED DEBRIDEMENT DUE TO OPEN WOUND. AFTER THE APPLICATION OF GENTAMICIN BONE CEMENT, THE PATIENT HAD SUDDEN DYSPNEA AND TACHYCARDIA. AFTER OBSERVATION BY THE SURGEON AND GLUCOSE FLUID INFUSION, THE PATIENT'S SYMPTOMS WERE SIGNIFICANTLY IMPROVED.
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. ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.