MAUDE report

MAUDE report 8513: TOTAL KNEE

Injury · received Feb 3, 1994 · HOWMEDICA, INC.

Key facts

MDR report key 8513
Report number 33274-1994-00009
Event type Injury
Brand name TOTAL KNEE
Catalog number UNKNOWN
Manufacturer HOWMEDICA, INC.
Product code HWC
Device class Class II
Date received by FDA Feb 3, 1994
Report date Jan 28, 1994
Report source Maude

At a glance

  • None Device problems coded
  • Yes Adverse event flagged
  • No 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:

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