MAUDE report

MAUDE report 83565: DEPUY

Injury · received Apr 9, 1997 · DEPUY, INC.

Key facts

MDR report key 83565
Report number 83565.2
Event type Injury
Brand name DEPUY
Model number 1014-68-000/630950016
Catalog number 1107-54-000/527590008
Manufacturer DEPUY, INC.
Product code KWB
Device class Class III
Date received by FDA Apr 9, 1997
Report date Feb 5, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 Injury reports for this brand
  • Yes Adverse event flagged
  • Yes Product problem flagged

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

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports