M-Vizion Femoral Revision System

Description of Event or Problem

The patient had a primary hip surgery on (b)(6) 2026. On (b)(6) 2026, revision surgery was due to a subsided stem and subsequent fracture below the lesser trochanter after 25 days from primary. The surgeon revised the Amistem P collared stem to a M-Vizion modular stem and revised the 40mm BIOLOX Delta Head M to a 40mm BIOLOX Delta Head L, along with implanting a proximal body. On (b)(6) 2026, the patient had signs of infection and the pathogen is unknown. The surgeon performed a washout and revised all implants (Medacta stem and head and competitor cup and liner) to new implants. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 23 July 2026: Stem: M-Vizion 01.22.102 Distal Stem D 13mm L 140mm straight (K170690) Lot 2416472: (b)(4) items manufactured and released on 04-Nov-2024. Expiration date: 20-Oct-2029. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Stem: M-Vizion 01.22.401 Proximal Body D 20mm L 40mm STD with holes (K201471) Lot 2426769: (b)(4) items manufactured and released on 15-Jan-2025. Expiration date: 18-Dec-2029. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Ball Heads: MectaCer 01.29.214 MECTACER Head Biolox Delta dia.40 12/14-L (K112115) Lot 2604588: (b)(4) items manufactured and released on 11-Mar-2026. Expiration date: 22-Feb-2031. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Root cause:Infection is a known possible complication of any surgery. Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.