MAUDE report

MAUDE report 8378: LG RT 7MM RESURFACING TIBIAL COMPONENT

Injury · received Aug 4, 1994 · HOWMEDICA, INC.

Key facts

MDR report key 8378
Report number 35434-1994-09002
Event type Injury
Brand name LG RT 7MM RESURFACING TIBIAL COMPONENT
Catalog number 6638-5-607
Manufacturer HOWMEDICA, INC.
Product code HSH
Device class Class II
Date received by FDA Aug 4, 1994
Report date May 31, 1994
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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