MAUDE manufacturer profile

EXACTECH, INC. · HSN

MAUDE profile for Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Key facts

Manufacturer EXACTECH, INC.
Manufacturer group EXACTECH, INC
Product code HSN
Product code name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Pain, Failure of Implant, Insufficient Information, Fracture, Naturally Worn, Loosening of Implant Not Related to Bone-Ingrowth Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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