MAUDE report

MAUDE report 65147: APR ACETABULAR INSERT 32MM/49MM

Injury · received Jan 28, 1997 · SULZER ORTHOPEDICS, INC.

Key facts

MDR report key 65147
Report number 2935620-1997-00002
Event type Injury
Brand name APR ACETABULAR INSERT 32MM/49MM
Catalog number 4300-32-049
Manufacturer SULZER ORTHOPEDICS, INC.
Product code KWB
Device class Class III
Date received by FDA Jan 28, 1997
Report date Jan 27, 1997
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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