NA 96-1682Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295239802), received between Feb 12, 2019 and Mar 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 16, 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.

• 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 11574697 ↗
• MalfunctionMar 3, 2020Device Slipped; Device Slipped

  BROACHES LOOSEN FROM HANDLE WHEN IMPACTED. THIS OCCURRED DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781752 ↗
• MalfunctionFeb 12, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE MBT REV PRIMARY REAMER WAS ROUNDED OFF WHERE IT ATTACHES TO THE HUDSON. MBT REV CAM STEM REAMER WAS ROUNDED OFF WHERE IT ATTACHES TO THE HUDSON. BROACH REAMER WAS CROSSED THREADED INSIDE. MODIFIED HUDSON ADAPTER WAS ROUNDED OFF AT THE CONTENTION. REV REAMER T HANDLE WAS ROUNDED OFF AT THE CONTENTION. REVISION FEMORAL BROACH HANDLE WAS WORN WHERE IT ATTACHES TO THE BROACHES AND WILL NO LONGER GRAB PROBABLY. THE TIP OF FEMORAL AUG PLUG PULLER WAS WORN DOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330849 ↗