SUMMIT
Received Jul 1, 2026 · Event occurred Jun 10, 2026
Report 1818910-2026-11328 · MDR key 25684574
Device
Generic name
Summit Hip Stem : Hip Femoral Stem
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
157013135
Lot number
D24034841
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
89 YR · Unknown
- Unspecified Infection
Narrative
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. ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER SEVERAL DISLOCATION AND THEN THE JOINT INFECTION THE PATIENT WAS BROUGHT TO SURGERY. ALL THE IMPLANTS WERE REMOVED. NO NEW IMPLANTS OR SPACERS WERE PLACED. THE IMPLANTS WERE INITIALLY PLACED ON SEVERAL DIFFERENT DATES TO TREAT HIS INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.