MAUDE report

MAUDE report 7875: PCA PRIMARY KNEE

Malfunction · received May 23, 1994 · HOWMEDICA, INC.

Key facts

MDR report key 7875
Report number 1722464-1994-09002
Event type Malfunction
Brand name PCA PRIMARY KNEE
Catalog number 6638-3-211/6638-1-960
Manufacturer HOWMEDICA, INC.
Product code JWH
Device class Class II
Date received by FDA May 23, 1994
Report date Mar 29, 1994
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
  • 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:

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