MAUDE report

MAUDE report 76567: CLS EXPANSION CUP 52MM

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

Key facts

MDR report key 76567
Report number 9613350-1997-00004
Event type Injury
Brand name CLS EXPANSION CUP 52MM
Catalog number 94.52.19
Manufacturer SULZER ORTHOPAEDICS 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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