MAUDE report

MAUDE report 45820: DURACON CONDYLAR TIBIAL INSERT

Malfunction · received Sep 16, 1996 · HOWMEDICA

Key facts

MDR report key 45820
Report number 2219689-1996-00052
Event type Malfunction
Brand name DURACON CONDYLAR TIBIAL INSERT
Catalog number 6632-1-219
Manufacturer HOWMEDICA
Product code HSH
Device class Class II
Date received by FDA Sep 16, 1996
Report date Sep 13, 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
  • 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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