NA 2178-63-196Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295096528), received between Dec 4, 2017 and May 24, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT WHEN PASSING THE CEMENTED REAMER THROUGH THE BUSHING IT GOT STUCK AND WOULD NOT CONTINUE REAMING. NEED NEW PARTS SENT TO (B)(6) WAREHOUSE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7542078 ↗
• MalfunctionApr 10, 2018Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DER STATES THAT INSTRUMENTATION BROKE IN SURGERY AND ALL PIECES WERE REMOVED FROM THE PATIENT WITH NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7411578 ↗
• MalfunctionDec 4, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE MBT REV 13 MM CEM BUSHING WAS NOTICED NOT PROPERLY FIT IN TOWER AFTER ASSEMBLING THE INSTRUMENTS AFTER CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7080384 ↗