HEMI HIP IMPLANT
Received Jul 7, 2026 · Event occurred Jun 12, 2026
Report 1818910-2026-11560 · MDR key 25737307
Device
Generic name
Hip Femoral Augment
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
136310000
Lot number
MC7366
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT THE HIP WAS INFECTED. SURGEON WANTED TO EXCHANGE THE HEAD AND SPACER. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.