NA 96-1684Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295239826), received between Nov 25, 2019 and May 8, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH WOULD NO LONGER LOCK THE STEM ONTO IT, AND THE WRENCH WOULD NOT MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888080 ↗
• MalfunctionAug 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM TRIAL WILL NOT FIT PROPERLY ON THE 45 MM TIBIA BROACH. STEM TRIAL WILL ALSO NOT FIT PROPERLY ON THE 34 MM AND THE 31 MM FEMORAL BROACH. 16 MM REAMER COMES LOOSE FROM THE HUDSON ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 12273581 ↗
• MalfunctionMar 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE REVISION KNEE SURGERY THE 34MM FEMORAL SLEEVE BROACH AND 14 X 115 STEM TRIAL GOT STUCK AND WAS HARD TO REMOVE. DURING THAT TIME THE REVISION FEMORAL BROACH HANDLE CAME OFF AND LANDED ON THE FLOOR. WE HAD TO GET IT RE-STERILIZED. WHILE WAITING THE SURGEON STARTED TRYING TO REMOVE WITH VICE GRIPS AND DAMAGED THE STEM TRIAL AND SLEEVE BROACH. WHEN WE DID GET THE HANDLE BACK IT WOULD NOT STAY ATTACHED TO THE BROACH SO I GUESS IT WAS DAMAGED AS WELL. ALL THREE INSTRUMENTS NEED REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574684 ↗
• MalfunctionNov 25, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  PROBLEM: IT IS VERY DIFFICULT TO CLEAN THE BROACH SLEEVE AND THE GASKETS. ACCORDING TO ATTACHED PICTURES THE BROACH SLEEVE IS STILL DIRTY AFTER CLEANING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369527 ↗