MAUDE report

MAUDE report 16659: DEPUY

Injury · received Feb 12, 1994 · DEPUY DIV., BOHERINGER MANNHEIM CORP.

Key facts

MDR report key 16659
Report number 16659
Event type Injury
Brand name DEPUY
Model number NI
Catalog number BALL: 1365-14-000
Manufacturer DEPUY DIV., BOHERINGER MANNHEIM CORP.
Product code KWL
Device class Class II
Date received by FDA Feb 12, 1994
Report date Nov 5, 1993
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
  • No 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