MAUDE manufacturer profile

DEPUY ORTHOPAEDICS INC US · KWS

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

Key facts

Manufacturer DEPUY ORTHOPAEDICS INC US
Manufacturer group JTE WARSAW MFG SITE
Product code KWS
Product code name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 1,000+ Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Code Available, Pain, Unspecified Infection, Device Dislodged or Dislocated, Joint Dislocation, Not Applicable, 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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