AMIStem H Femoral Stems

Description of Event or Problem

Revision surgery due to stem loosening after about 12 years and 2 months from primary. The surgeon revised the Medacta head and stem to a competitor head and and stem and revised the Medacta Double Mobility D 28 liner to a same size liner.

Additional Manufacturer Narrative

Batch review performed on 22 July 2026 Amistem H 01.18.130 AMIStem-H Std. size 0 Lot. 133052: (b)(4) items manufactured and released on 16-Sep-2013. Expiration date: 2018-08-31. 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:Aseptic loosening is a possible literature-described adverse event following arthroplasties and causes are often unknown. There is no indication that any potential issue with the device may have caused or contributed to the event.