MAUDE report

MAUDE report 5734: PCA REVISION TIBIAL COMPONENT 22MM

Injury · received Apr 29, 1993 · HOWMEDICA, INC.

Key facts

MDR report key 5734
Report number 34251-1993-00001
Event type Injury
Brand name PCA REVISION TIBIAL COMPONENT 22MM
Catalog number 6639-3-222
Manufacturer HOWMEDICA, INC.
Product code JWH
Device class Class II
Date received by FDA Apr 29, 1993
Report date Mar 1, 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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