CEM REV/CALCAR ST SZ 17X230MM
Received May 19, 2026 · Event occurred Apr 28, 2026
Report 0002648920-2026-00079 · MDR key 25215934
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Zimmer Manufacturing B.v.Catalog number
00787101761
Lot number
65485786
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
55 YR · Unknown
- Joint Dislocation
- Medical device site infection
- Septic loosening
Narrative
Additional Manufacturer Narrative
(B)(4) PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO INFECTION, DISLOCATION AND LOOSENING OF THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.