G7 CURVED INSERTER THD SHAFT
Received Jul 16, 2026 · Event occurred Jun 26, 2026
Report 0001825034-2026-02090 · MDR key 25839008
Device
Generic name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Manufacturer
Zimmer Biomet, Inc.Catalog number
110003454
Lot number
396790
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). 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 DURING CUP IMPACTION, AN INSTRUMENT HAD A PIECE CRACK OFF AFTER THE HANDLE WAS DISENGAGED. THE EVENT OCCURRED INTRA-OPERATIVELY DURING CUP PLACEMENT, ALL FRAGMENTS WERE RETRIEVED, AND THERE WAS NO SURGICAL DELAY. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.