MAUDE report

MAUDE report 50063: DURACON TIBIAL INSERT

Injury · received Nov 18, 1996 · HOWMEDICA, INC.

Key facts

MDR report key 50063
Report number 2219689-1996-00232
Event type Injury
Brand name DURACON TIBIAL INSERT
Catalog number 6630-1-809
Manufacturer HOWMEDICA, INC.
Product code HSH
Device class Class II
Date received by FDA Nov 18, 1996
Report date Nov 15, 1996
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
  • 1–9 Injury reports for this brand
  • Yes 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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