SMS Stem
Received Jul 27, 2026 · Event occurred Jul 17, 2026
Report 3005180920-2026-00791 · MDR key 50005866
Device
Generic name
Sms Collared Solid Stem Std Size9
Manufacturer
Medacta International SaModel number
01.36.149Lot number
2209145
Product problems
- Osseointegration Problem
Patient
Unknown
- Inadequate Osseointegration
- Implant Pain
- Aseptic loosening
Narrative
Description of Event or Problem
Revision surgery due to stem loosening after about 3 years after primary. The surgeon revised the Medacta stem with a competitor stem and revised Medacta head and liner with a new Medacta head and liner.
Additional Manufacturer Narrative
Batch review performed on 23 July 2026: Lot 2209145: (b)(4) items manufactured and released on 28-Sep-2022. Expiration date: 19-Sep-2027. No anomalies found related to the problem. To date, (b)(4) the items of the same lot have been sold with no similar reported event during the period of review. Root cause: