G7
Received Jul 8, 2026 · Event occurred Jun 17, 2026
Report 0001825034-2026-02020 · MDR key 25752471
Device
Generic name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Manufacturer
Zimmer Biomet, Inc.Catalog number
110003450
Lot number
UNK
Product problems
- Fracture
- Damaged Thread
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE SCREWING ON THE HANDLE IT WAS CATCHING. ON REVIEW OF THE INSTRUMENT, THE THREADS APPEARED TO BE COMING OFF. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN, EVENT OCCURRED IN AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.