NA 2178-63-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295096221), received between Dec 21, 2017 and Nov 20, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIAL POST WAS BROKEN, THE WRENCH ROD FOR TORQ WAS BENT AND WOULD NOT TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609165 ↗
• MalfunctionSep 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPENED DURING A SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DEVICE IS BROKEN IN ITS PROXIMAL PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993171 ↗
• MalfunctionOct 30, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT IT BROKE INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030431 ↗
• MalfunctionJun 6, 2022Break; Break

  THE LONG BLUE TC3 REVISION TRIAL POST BROKE INTO TWO PIECES WHEN TRYING TO SEAT THE TRIAL INSERT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603274 ↗
• MalfunctionOct 25, 2021Crack; Device-Device Incompatibility; Naturally Worn; Crack; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE GUIDE POST IS NOT ABLE TO LOCATE INTO TRIAL AND IS WORN/CRACKED. NO PATIENT IMPACT OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12690022 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED THAT THE RP TRIAL POST SNAPPED UPON REMOVAL. THE SURGEON EXTRACTED BOTH PARTS OF THE 2 PIECE TRIAL POST AND CONFIRMED NONE OF THE INSTRUMENT WAS LEFT IN THE TRAY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281026 ↗
• MalfunctionAug 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERT HAS A SMALLER INNER DIAMETER THAN THE TRIAL POST AND CANNOT BE ATTACHED TO IT. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12273488 ↗
• MalfunctionApr 20, 2021Crack; Crack

  IT WAS REPORTED THAT THE MBT REV TRIAL POST IS CRACKED AND NEEDS TO BE REPLACED. SURGERY TIME WAS NOT EXTENDED. THE MIDDLE PART, CLOSE TO WHERE YOU PUT THE TRIAL INSERT WAS THE PART THAT CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697609 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL POST BROKE DURING TRIALING. NO SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793273 ↗
• MalfunctionNov 7, 2019Break; Break

  IT WAS REPORTED THAT BLUE REVISION POST WAS BROKEN DURING SURGERY. IT BROKE INTO TWO PIECES WHICH WERE BOTH REMOVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290540 ↗
• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED THAT DURING TRAILING OF THE REVISION INSERT THE BLUE REVISION RP TRIAL POST CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957561 ↗
• MalfunctionAug 31, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS OUT OF AN OFFICE SET. DID NOT AFFECT A SURGERY. DID NOT AFFECT ANY PATIENT. NO PIECES WERE LEFT IN A PATIENT. PART IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837261 ↗
• MalfunctionDec 21, 2017Break; Break

  DER STATES THAT WHEN TRIALING THE LPS INSERT, THE INSERT TRIAL CHIPPED OFF A PIECE OF THE BLUE POST. ALL PIECES WERE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137684 ↗