Quadra H femoral stems
Received Jul 27, 2026 · Event occurred Jul 17, 2026
Report 3005180920-2026-00797 · MDR key 50005857
Device
Generic name
Quadra Stem Standard Hap 12/14 S.7
Manufacturer
Medacta International SaModel number
01.12.027Lot number
090002
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Male
- Osteolysis
Narrative
Description of Event or Problem
The patient had evidence of osteolysis behind the competitor cup and proximal femur and the cause is unknown. At about 17 years and 1 month post primary the surgeon revised the competitor cup and liner, revised the Medacta head, and added a sleeve. The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 July 2026: Lot 090002: (b)(4) items manufactured and released on 06-Mar-2009. Expiration date: 31-Jan-2014. No anomalies found related to the problem. To date, all the 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, the cause of the reported osteolysis cannot be definitively established. The osteolysis was observed behind the competitor acetabular cup and in the proximal femur, while no specific issue involving the Medacta components was reported. The available investigation does not indicate that a Medacta device-related issue caused or contributed to the event.