K082924

Substantially Equivalent

DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER

Applicant: Wrightmedicaltechnologyinc
Product code: KWA
Advisory panel: Orthopedic
Date received: 2008-10-01
Decision date: 2009-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington, TN, US

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.