MAUDE report

MAUDE report 6630: VARIABLE AXIS KNEE TIBIA INSERT

Injury · received Sep 28, 1993 · HOWMEDICA, INC.

Key facts

MDR report key 6630
Report number 34534-1993-00004
Event type Injury
Brand name VARIABLE AXIS KNEE TIBIA INSERT
Catalog number 2627-2-907
Manufacturer HOWMEDICA, INC.
Product code HSH
Device class Class II
Date received by FDA Sep 28, 1993
Report date Sep 15, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 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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