MODULAR CATHCART BALL 43MM OD
Received Jun 30, 2026 · Event occurred Jun 8, 2026
Report 1818910-2026-11155 · MDR key 25665807
Device
Generic name
Hemi Hip Implant : Hip Acetabular Metal Hemi
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
136343000
Lot number
D25112539
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Female
- 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. 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 PATIENT SHOWED SIGNS OF INFECTION. SURGEON WAS NOT SURE IF THE INFECTION WAS INTO THE JOINT OR NOT. SURGEON ELECTED TO DO A HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.