CONTINUUM TRABECULAR METAL
Received Jul 17, 2026 · Event occurred Jun 26, 2026
Report 0001822565-2026-02606 · MDR key 25856325
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
00875705002
Lot number
67390850
Product problems
- Adverse Event Without Identified Device or Use Problem
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Male
- Pain
- Aseptic loosening
- Periprosthetic fracture
Narrative
Description of Event or Problem
IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO PAIN, LOOSE CUP, AND PELVIS FRACTURE. POST-OPERATIVE PHOTOS SHOWED THE CUP HAD COME LOOSE. BECAUSE THE PELVIS WAS FRACTURED, ANTIBIOTIC CEMENT WAS APPLIED TO THE HEAD BEFORE CLOSURE. ALL IMPLANTS HAVE BEEN REMOVED. A NEW CUP AND LINER WAS NOT IMPLANTED. THERE WAS A SURGICAL DELAY OF 180 MINUTES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). D10: UNK ZIMMER BIOMET HEAD; UNK COMPETITOR STEM CAT# 00875800928 LOT# 66433114 28MM I.D. SIZE HH WITH CONSTRAINING RING CONSTRAINED LINER 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.