ACTIS
Received Jul 22, 2026 · Event occurred Jun 29, 2026
Report 1818910-2026-12495 · MDR key 25906972
Device
Generic name
Hip Implant - Hip Femoral Stem
Manufacturer
Depuy Ireland - 3015516266Catalog number
101021110
Lot number
M3231U
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS INFECTED SO THE PRIMARY HIP COMPONENTS WERE REMOVED. PROSTALAC STEM AND EMPHSYS LINER WERE CEMENTED IN PLACE AS A TEMPORARY ANTIBIOTIC SPACER. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.