K130610

Substantially Equivalent

SIRIUS FEMORAL STEM

Applicant: Biomet, Inc.
Product code: JDI
Advisory panel: Orthopedic
Date received: 2013-03-07
Decision date: 2013-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.