MODULAR CATHCART TAPERED SPACER 12/14 TAPER +5MM
Received Jul 15, 2026 · Event occurred Jun 22, 2026
Report 1818910-2026-11981 · MDR key 25827305
Device
Generic name
Hemi Hip Implant : Hip Femoral Augment
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
136312000
Lot number
MG9267
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HEAD BALL AND TAPER REPLACEMENT DUE TO INFECTION. DOI-(B)(6) 2026 DOR-(B)(6) 2026 AFFECTED SIDE-RIGHT HIP.