UNK STEM
Received Jul 9, 2026 · Event occurred Jun 16, 2026
Report 0001822565-2026-02499 · MDR key 25761285
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Unknown
- Joint Dislocation
- Unequal Limb Length
Narrative
Additional Manufacturer Narrative
(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 THE PATIENT EXPERIENCED A DISLOCATION FOLLOWING A TOTAL FEMORAL REPLACEMENT AND UNDERWENT REVISION APPROXIMATELY SIX WEEKS POST-IMPLANTATION; THE TOTAL FEMUR PROXIMAL BODY WAS CHANGED TO INCREASE LEG LENGTH AND OFFSET, AND THE CONSTRAINED LINER WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.