Orthomatch 71436399Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556622087), received between Sep 22, 2020 and Feb 18, 2026 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A RIGHT TKA SURGERY, AT THE MOMENT OF FINAL IMPACT OF THE FEMORAL IMPLANT, AFTER CEMENTATION, A PART OF THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379500 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AT THE TIME OF IMPACTING THE COMPONENT WITH ONE (1), ORTHOMATCH CR IMPLANT IMPACTOR BROKE INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT ORTHOMATCH CR IMPLANT IMPACTOR BACK UP AND WITH THE SAME ORTHOMATCH MOD FEM TRIAL IMPACTOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816512 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, AT THE TIME OF IMPACTING THE FEMUR DURING CEMENTING, THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000291 ↗
• MalfunctionAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR BROKE IN HALF WHILE IMPACTING THE FINAL IMPLANT. THERE WAS NO BREAKAGE WITHIN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892388 ↗
• MalfunctionNov 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING FEMORAL COMPONENT IMPACTION IN A TKA SURGERY, ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR BROKE. THE PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805771 ↗
• MalfunctionNov 25, 2024Crack; Fracture; Material Deformation; Crack; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, AN ORTHOMATCH CR IMPLANT IMPACTOR WAS DAMAGED INTRAOPERATIVELY AFTER SOME HAMMER STRIKES. PROVIDED PICTURES SHOWS A FRACTURE IN THE DEVICE. THERE WAS NO BREAKAGE INTO PIECES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772579 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHEN THE FEMUR TRIAL WAS IMPACTED, THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE IN TWO PIECES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344270 ↗
• MalfunctionSep 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHEN THE IMPLANT WAS IMPACTED, THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170868 ↗
• MalfunctionApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR FRACTURED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142447 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR IS FOUND BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075187 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR BROKE UPON IMPACTING THE IMPLANT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221376 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHEN USING THE ORTHOMATCH CR IMPLANT IMPACTOR, A PART OF IT CAME LOOSE ON THE TABLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121525 ↗
• MalfunctionJun 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ON INITIAL IMPACTION ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113810 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE MODULAR CR FEMORAL IMPACTOR BODY OF ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR BROKE WHILE IMPACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718024 ↗
• MalfunctionFeb 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, ONE (1) ORTHOMATCH CR IMPLANT IMPACTOR BROKE DURING USE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROCEDURE WAS FINISHED, HOWEVER, PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372823 ↗
• MalfunctionDec 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT AN ORTHOMATCH CR IMPLANT IMPACTOR IS BROKEN. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926004 ↗
• MalfunctionSep 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE MODULAR CONNECTOR AND THE BODY OF AN ORTHOMATCH CRUCIATE RETAINING IMPLANT IMPACTOR FRACTURED. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492047 ↗
• InjuryApr 19, 2022Break; Break

  IT WAS REPORTED THAT DURING THR, WHILE IMPACTING THE FEMORAL TRIAL, THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE WHILE INSIDE THE PATIENT. A CHANGE IN SURGICAL TECHNIQUE WAS NEEDED. A DELAY GREATER THAN 30 MINS WAS REPORTED. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140899 ↗
• MalfunctionOct 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A ORTHOMATCH CR IMPLANT IMPACTOR BROKE WHEN IMPACTED INTO THE FEMUR. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719607 ↗
• InjurySep 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AN ORTHOMATCH CRUCIATE RETAINING IMPLANT IMPACTOR BROKE OFF WHEN IMPACTED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE INSTEAD, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475518 ↗
• InjurySep 1, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA, WHEN INSTALLING THE ORTHOMATCH CR IMPLANT IMPACTOR, IT WAS CRACKED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410591 ↗
• InjuryJun 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A ORTHOMATCH MODULAR CR FEMORAL IMPLANT IMPACTOR BROKE WHILE INSTRUMENTS WERE INSIDE THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076503 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A ORTHOMATCH CR IMPLANT IMPACTOR BROKE. INSTRUMENT OUTSIDE THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803402 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT, BEFORE SURGERY, THE ORTHOMATCH CR IMPLANT IMPACTOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTE DELAY, USING A S+N BACK-UP DEVICE. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744170 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT DURING USE OF A ORTHOMATCH CR IMPLANT IMPACTOR, THE IMPACTOR BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND IT WAS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729684 ↗