MAUDE report
MAUDE report 8475: PCA UNI TIBIAL COMPONENT MED./LG 9MM LT. LAT/RT. MED.
Injury · received Feb 3, 1994 · HOWMEDICA, INC.
Key facts
| MDR report key | 8475 |
|---|---|
| Report number | 33462-1994-01132 |
| Event type | Injury |
| Brand name | PCA UNI TIBIAL COMPONENT MED./LG 9MM LT. LAT/RT. MED. |
| Catalog number | 6635-4-309 |
| Manufacturer | HOWMEDICA, INC. |
| Product code | HSH |
| Device class | Class II |
| Date received by FDA | Feb 3, 1994 |
| Report date | Jan 10, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 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: