MAUDE manufacturer profile

MEDACTA INTERNATIONAL SA · KRO

MAUDE profile for Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Key facts

Manufacturer MEDACTA INTERNATIONAL SA
Manufacturer group MEDACTA INTERNATIONAL SA
Product code KRO
Product code name Prosthesis, Knee, Femorotibial, 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
  • Unspecified Infection, Device Appears to Trigger Rejection, Appropriate Term/Code Not Available, Peri-prosthetic Joint Infection, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Break, Fracture 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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