36MM COCR MOD HD +3MM
Received Jul 13, 2026
Report 0001825034-2026-02041 · MDR key 25796220
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
11-363663
Lot number
206250
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Bursitis
Narrative
Additional Manufacturer Narrative
(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD 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 HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 6 YEARS LATER DUE TO PAIN AND SLIGHTLY ELEVATED CHROMIUM LEVELS. THE INITIAL STEM WAS LEFT INTACT WHILE ALL OTHER COMPONENTS WERE REPLACED WITHOUT COMPLICATIONS. AFTER THE REVISION, THE PATIENT REPORTED ONGOING PAIN IN BILATERAL HIPS. THE SURGEON STATED HE FELT THE PATIENT HAD BILATERAL HIP TROCHANTERIC BURSITIS AND DISCUSSED INJECTIONS WITH THE PATIENT; HOWEVER, THE PATIENT DECLINED TREATMENT AND INTERVENTIONS. THE PATIENT TAKES CHRONIC OPIOIDS AND IS FOLLOWED BY PAIN MANAGEMENT FOR POLYARTHRALGIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.