MAUDE report

MAUDE report 6616: HARRIS GALANTE II ACETABULAR CUP LINER

Injury · received Sep 20, 1993 · ZIMMER PROSTHETIC IMPLANT DIVISION

Key facts

MDR report key 6616
Report number 33458-1993-00007
Event type Injury
Brand name HARRIS GALANTE II ACETABULAR CUP LINER
Catalog number 6728-
Manufacturer ZIMMER PROSTHETIC IMPLANT DIVISION
Product code JDL
Device class Class III
Date received by FDA Sep 20, 1993
Report date Jul 14, 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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