MAUDE report

MAUDE report 76549: CLS EXPANSION CUP 48MM

Injury · received Mar 18, 1997 · SULZER ORTHOPEDICS LTD.

Key facts

MDR report key 76549
Report number 9613350-1997-00001
Event type Injury
Brand name CLS EXPANSION CUP 48MM
Catalog number 94.48.19
Manufacturer SULZER ORTHOPEDICS LTD.
Product code KWB
Device class Class III
Date received by FDA Mar 18, 1997
Report date Mar 18, 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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