InjuryJDI
ITPRLC MP HO TI 5X95MM T1
Received Jul 16, 2026 · Event occurred Jun 22, 2026
Report 0001825034-2026-02085 · MDR key 25838498
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S CALCAR FRACTURED WHEN THE SURGEON INSERTED AN OFFSET FEMORAL STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. G2: FOREIGN - EVENT OCCURRED IN JAPAN. 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.