MAUDE manufacturer profile

BIOMET FRANCE S.A.R.L. · KWS

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

Key facts

Manufacturer BIOMET FRANCE S.A.R.L.
Manufacturer group BIOMET FRANCE S.A.R.L.
Product code KWS
Product code name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Difficult to Insert, No Consequences Or Impact To Patient, Joint Dislocation, Device Dislodged or Dislocated, No Information, Adverse Event Without Identified Device or Use Problem, Pain, Bone Fracture(s) 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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