Quadra P femoral stems
Received Jul 27, 2026 · Event occurred Jul 17, 2026
Report 3005180920-2026-00787 · MDR key 50005867
Device
Generic name
Quadra-p Lat Stem Size1
Manufacturer
Medacta International SaModel number
01.12.141Lot number
1908588F
Product problems
- Fracture
Patient
69 YR · Female
- Bone Fracture(s)
Narrative
Description of Event or Problem
Revision surgery due to calcar fracture after about 1 month from primary. The surgeon revised the stem and the head.
Additional Manufacturer Narrative
Batch review performed on 22 July 2026: Lot 1908588F: (b)(4) items manufactured and released on 09-Mar-2020. Expiration date: 2025-Feb-25. 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. The 12 remaining devices, were re-sterilized and, to date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review. Root cause: