K192967

Substantially Equivalent

Medacta Shoulder System

Applicant: Medacta International S.A.
Product code: PHX
Advisory panel: Orthopedic
Date received: 2019-10-23
Decision date: 2020-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.