NA 2178-63-113Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295096108), received between Jun 25, 2018 and Sep 2, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE O-RING WAS DETACHED FROM INSIDE OF BROACH. THE INSTRUMENT IS UNABLE TO HOLD STEM TRIALS. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939957 ↗
• MalfunctionMay 25, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE IS WORN/BROKEN AFTER REPEATED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002296 ↗
• 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 12273586 ↗
• MalfunctionJul 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOTH HUDSON ADAPTORS WOULD NOT HOLD THE 16 MM REAMER. BOTH THE HUDSON¿S AND THE REAMER NEEDS TO BE REPLACED. BOTH OF THE TIBIAL BROACHES WOULD NOT HOLD A STEM TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242296 ↗
• MalfunctionMay 18, 2020Material Discolored; Device-Device Incompatibility; Material Discolored; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL BROACH WOULDN¿T RETAIN THE STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067710 ↗
• MalfunctionDec 16, 2019Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 37 MBT REVISION BROACH APPEARED TO BE MANUFACTURED IN A WAY THAT IT WAS NOT COMPATIBLE WITH THE MBT REVISION BROACH HANDLE. BROACHES HAD TO BE MALLETED IN AND EXTRACTED WITHOUT THE BROACH HANDLE 45 ALSO APPEARS TO BE THE SAME. THERE WAS A 20-25 MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9476761 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WILL NOT LOAD INTO HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240773 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WILL NOT LOAD INTO HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240076 ↗
• MalfunctionSep 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM TRIALS WILL NOT CONNECT TO BROACHES. NEEDS REPLACEMENT VIA (B)(6) TO (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8957421 ↗
• MalfunctionMar 29, 2019Component Missing; Material Deformation; Naturally Worn; Component Missing; Material Deformation; Naturally Worn

  THE 2 INSTRUMENTS ARE WORN AND THE COUPLING MECHANISM HAS BECOME FAULTY DUE TO THE STEM RETAINING RING IN THE COUPLING MECHANISM, HAVING BEEN LOST. THIS DID NOT OCCUR DURING A PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465381 ↗
• MalfunctionFeb 19, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE WAS WITH DIFFICULTY WITH A FEW DIFFERENT INSTRUMENTS ON THIS CASE. THE 45MM TIBIAL BROACH WOULD NOT CONNECT WELL WITH THE STEM EXTENSION TRIAL. THE TC FEMORAL BOX TRIAL WOULD KEEP UNSNAPPING OFF THE FEMORAL COMPONENT TRIAL AND WOULDN'T LOCK ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350656 ↗
• MalfunctionJan 17, 2019Component Missing; Component Missing

  WORN INSTRUMENTS, NEED TO BE REPLACED. SOME OF THE "O RINGS" ARE MISSING FROM THE REAMERS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258655 ↗
• MalfunctionNov 2, 2018Material Deformation; Material Deformation

  O-RING HAS DETERIORATED INSIDE TRIAL SLEEVE AND TIBIAL BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033745 ↗
• MalfunctionOct 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR AND SCRUB NURSE STRUGGLED CONNECTING BROACHES AND REAMERS TO TRIAL STEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019185 ↗
• MalfunctionOct 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE 4 BROACHES FOR THE TIBIAL SLEEVES DO NOT ATTACH TO THE UNIVERSAL SLEEVE TRIALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970047 ↗
• MalfunctionJun 25, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE TIBIAL BROACHES ARE MISSING THE RUBBER RING INSIDE THE BROACHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635314 ↗