SMS Stem

Description of Event or Problem

Revision surgery due to a fractured femur after about 2 years and 5 months from primary. The surgeon cabled the fracture and revised the Medacta stem and head to a competitor stem and head, and the Hooded PE HC liner to a Flat PE HC.

Additional Manufacturer Narrative

Batch review performed on 22 July 2026: Lot 2304286: (b)(4) items manufactured and released on 15-Jun-2023. Expiration date: 2028-May-28. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review. Root cause: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.