ZB 12/14 COCR HD 28MM X +3.5
Received Jul 14, 2026 · Event occurred Jun 22, 2026
Report 0002648920-2026-00130 · MDR key 25816189
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Manufacturer
Zimmer Manufacturing B.v.Catalog number
802202803
Lot number
67559019
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Arthritis
- Bacterial Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 18 DAYS POST-IMPLANTATION DUE TO PURULENT ARTHRITIS FOLLOWING A TOTAL HIP ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. D10: CAT# 11-165218 LOT# 67454487 RINGLOC BI-POLAR 28X47MM. 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.