InjuryJDI
UNK CUP
Received Jul 17, 2026
Report 0001822565-2026-02602 · MDR key 25853852
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4) D10: UNK ZMR STEM. 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 IS BEING CONSIDERED FOR A CUSTOM TRIFLANGE PRODUCT DUE TO UNKNOWN REASONS. THE SURGEON IMPLANTED AN ALL POLY CUP ON AN UNKNOWN DATE AS A TEMPORARY IMPLANT WHILE THE TRIFLANGE IS MADE. A FULL REVISION HAS NOT YET TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.