MAUDE report

MAUDE report 4565: POLYSULFONE COMPOSITE HIP STEM

No Answer Provided · received Jul 1, 1992 · BIOMET INC.

Key facts

MDR report key 4565
Report number 4565
Event type No Answer Provided
Brand name POLYSULFONE COMPOSITE HIP STEM
Model number STEM-RD105413
Manufacturer BIOMET INC.
Product code KMC
Device class Class II
Date received by FDA Jul 1, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • Yes 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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