RINGLOC BI-POLAR 28X47MM
Received Jul 14, 2026 · Event occurred Jun 22, 2026
Report 0001825034-2026-02069 · MDR key 25816225
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
11-165218
Lot number
67454487
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Arthritis
- Bacterial Infection
Narrative
Additional Manufacturer Narrative
(B)(4). D10: CAT# 802202803 LOT# 67559019 FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH. G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY AND WAS REVISED APPROXIMATELY 18 DAYS POST-IMPLANTATION DUE TO PURULENT ARTHRITIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.