MAUDE report

MAUDE report 22165: PCA PRIMARY KNEE

Injury · received Apr 5, 1995 · HOWMEDICA, INC.

Key facts

MDR report key 22165
Report number 33448-1995-00011
Event type Injury
Brand name PCA PRIMARY KNEE
Catalog number 6638-3-500
Manufacturer HOWMEDICA, INC.
Product code HTG
Device class Class II
Date received by FDA Apr 5, 1995
Report date Apr 5, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 Injury reports for this brand
  • 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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