LIVING PMS Dashboard: Zimmer Ascendant Acetabular System
ISO 13485 | MAS-p2d
PMS Plan
Due: Immediate
Literature Search Plan
Due: Immediate
Safety Database Search Plan
Due: Immediate
PMCF Plan
Due: Immediate
PSUR/PMS Report
Next Report Due: Oct 2025
PMCF Report
Action Required
User Survey Data: Due
Due
Literature Search Report
Review Required
16 new publications found
16 new
Safety Database Search Report
HIGH ALERT
2 new SAEs & 3 FSCAs detected
HIGH ALERT
Trend Report
Review Required
Statistically significant increase in AEs
Upstream Links
- •TechDoc DossierApprove Updates to IFU, GSPR
Lateral Links
- •Risk Management – BERApprove 6 section updates
- •Clinical Evaluation ReportApprove 3 section updates
- •Quality Management System – CAPAApprove record updates