ORTHOMATCH 71442165Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556495100), received between Jun 16, 2018 and Jul 2, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) ORTHOMATCH TIB ALIGN M/L TRANS TUBE BROKE WHEN IT WAS BEING POSITIONED IN THE TIBIA. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391466 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY THE ORTHOMATCH TIB ALIGN M/L TRANS TUBE BROKE WHEN ADJUSTING THE ALIGNMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. ALTHOUGH, THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735735 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A ARTHROSCOPY SURGERY THE ORTHOMATCH TIB ALIGN M/L TRANS TUBE BROKE, NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511211 ↗
• MalfunctionJul 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, BEFORE THE ORTHOMATCH TIBIAL ALIGN M/L TRANS TUBE WAS PLACED ON THE PATIENT, IT WAS ASSEMBLED AS REGULAR AND WHEN THE DEVICE WAS SQUEEZED IT JUST CAME OUT IN THE HAND DISASSEMBLING IT AS IT WAS BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE BY HOLDING IT WITH THE HAND. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973819 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, AN ORTHOMATCH TIBIAL ALIGN M/L TRANS TUBE WAS OBSERVED TO BE BROKEN. THIS WAS NOTICED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927463 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT DEVICE BROKE DURING THE PROCEDURE WHILE PERFORMING TIBIAL ALLIGNMENT. BACK UP AVAILABLE. A 30MIN-1 HR DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370451 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIBIAL ALIGNMENT GUIDE TUBE BROKE WHILST BEING TIGHTENED. DELAY OF LESS THAN 30MIN REPORTED. NO INJURY REPORTED. NO BACK UP REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218119 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE ORTOMATCH TIBIAL BOLT WAS BROKEN, NO PROCEDURE, DELAY, INJURY OR BACK UP REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059527 ↗
• MalfunctionOct 31, 2018Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION OF ANTHEM KNEE JOINT IMPLANTATION, A DISTAL PART OF THE TUBE OF THE TIBIAL GUIDE BROKE.

  Patient problems: No Information

  MAUDE report 8025857 ↗
• MalfunctionOct 31, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALFUNCTION OCCURRED. WHEN TIGHTENING THE TIBIAL ALIGNMENT ASSEMBLY DURING TKR, THE PLASTIC ROD BROKE. SURGEON SWITCHED TO GENII METAL TIBIA ALIGNMENT JIG.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8025315 ↗
• MalfunctionOct 15, 2018Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION OF ANTHEM KNEE JOINT IMPLANTATION, A DISTAL PART OF THE TUBE OF THE TIBIAL GUIDE BROKE. NO DELAY OR INJURY REPORTED. NO BACK UP REPORTED.

  Patient problems: No Information

  MAUDE report 7965054 ↗
• MalfunctionSep 26, 2018Break

  IT WAS REPORTED THAT DURING THE OPERATION OF ANTHEM KNEE JOINT IMPLANTATION, A DISTAL PART OF THE TUBE OF THE TIBIAL GUIDE BROKE. THERE WERE NO BROKEN PIECES OF THE INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7912362 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE SURGERY. THERE WAS NO BACKUP DEVICE AVAILABLE. NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Information

  MAUDE report 7866147 ↗
• InjuryJun 16, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHEN TIGHTENING THE TIBIAL ALIGNMENT ASSEMBLY, THE PLASTIC ROD BROKE, SUBSEQUENTLY, THE SURGEON HAD TO SWITCHED TO AN INTRA-MODULARY TECHNIQUE TO COMPLETE THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7608446 ↗