AMIStem H Femoral Stems

Description of Event or Problem

Revision surgery due to pain after about 4 years and 4 months from first revision surgery. The surgeon elected to revise the Medacta head and stem to competitor head and stem. The patient had primary left hip surgery on (b)(6) 2017. On (b)(6) 2022, the patient came in reporting pain which was believed to be a loose stem. The stem was not revised, but the surgeon did revise the head from a 36mm Biolox S to a 36mm Biolox M.

Additional Manufacturer Narrative

Batch review performed on 23 July 2026 Amistem H 01.18.132 AMIStem-H Std. # 2 (K093944) Lot. 163829: (b)(4) items manufactured and released on 12 October 2016. Expiration date: 27 September 2021. No anomalies found related to the problem. To date, all items of the same lot have been sold with no similar reported event during the period of review. MectaCer 01.29.209 MECTACER Head Biolox Delta dia.36 12/14-M (K112115) Lot. 2105988: (b)(4) items manufactured and released on 09 September 2021. Expiration date: 24 August 2026. No anomalies found related to the problem. To date, all items of the same lot have been sold with no similar reported event during the period of review. Root cause: Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.