AMIStem H Femoral Stems

Description of Event or Problem

The patient reported persistent right hip pain. Radiographic osteoarthritis of the right hip was confirmed by CT arthrography. Revision surgery was performed at14 years and 6 months after the primary surgery. Stem, liner, head and cup were successfully revised.

Additional Manufacturer Narrative

Batch review performed on 17 Jul 2026 Stem: Amistem H 01.18.144 AMIStem-H Lat. size 4 (K093944) Lot 112827: (b)(4) items manufactured and released on 15-Dec-2011. Expiration date: 2016-Sept-16. 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. Liner: CC e CC Light 01.26.2839HCT Flat PE HC Liner D 28/C (K103352) Lot 113807: (b)(4) items manufactured and released on 20-Dec-2011. Expiration date: 2016-nov-31. 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. Cup: Versafitcup CC Light 01.26.48MBTL VERS. CUP CC LIGHT METAL BACK 48 MM (not registered in US) Lot 112834: (b)(4) items manufactured and released on 19-Dec-2011. Expiration date: 2016-Oct-31. 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.