ORTHOMATCH 71442161Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556583791), received between Feb 5, 2019 and Dec 18, 2025 — classified as 2 injuries, 18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, DURING IMPACTION ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE , WHICH LED TO A SMALL FRAGMENT FALLING INTO THE WOUND. THE FRAGMENT WAS REMOVED WITH FORCEPS AND THE INSTRUMENT WAS CONTINUED TO BE IMPACTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838173 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE UPON IMPACT. 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 23816361 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE AT THE TIME OF IMPLANT PLACEMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060953 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE REPLACEMENT PROCEDURE, WHEN THE FEMUR WAS IMPACTED, A PIECE OF ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR CRACK AND BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531977 ↗
• MalfunctionMay 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY AT THE TIME OF PLACEMENT OF THE TEST FEMORAL COMPONENT, THE ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970541 ↗
• MalfunctionMay 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE BODY OF A ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE WHEN IMPACTING THE FEMORAL TRIAL. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924568 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE. NO PIECES FELL INTO THE WOUND. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946468 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT DURING TKA, THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE OUTSIDE PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722730 ↗
• InjuryJul 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE WHEN IMPACTING AND PIECES FELL INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159140 ↗
• InjuryMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE PARTIALLY INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817093 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT, THE IMPACTOR WAS BROKEN DURING SURGERY. INSTRUMENTS WERE OUTSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS ANY DELAY OR HOW THE PROCEDURE WAS FINISHED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385952 ↗
• MalfunctionFeb 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY WHEN PERFORMING THE IMPACTION OF THE FEMORAL TEST, THE ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE IN THE CONTACT PART OF THE METAL WITH POLYETHYLENE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347203 ↗
• MalfunctionJan 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING EXAMINATION AFTER AN UNKNOWN PROCEDURE, PARTIAL DESTRUCTION OF THE IMPACTOR WAS REVEALED. THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144618 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT, DURING INSTRUMENTS SET INSPECTION, A FRACTURE OF THE TRIAL FEMORAL IMPACTOR WAS FOUND. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11026948 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE IMPACTOR BROKE. NO DELAY OR HARM TO THE PATIENT REPORTED. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORM OR HOW WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10611070 ↗
• MalfunctionApr 8, 2020Break; Break

  IT WAS REPORTED THAT THE IMPACTOR BROKE DOWN DURING SURGERY. THE DEVICE BROKE OUTSIDE THE PATIENT AND NO PIECES FELL INSIDE THE SURGICAL INCISION. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S AND N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935271 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT TRIAL IMPACTOR BROKE WHILE BEING USED DURING SURGERY. NO DELAY OR INJURY REPORTED.

  Patient problems: No Information

  MAUDE report 8722174 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE IMPACTOR BROKE. LESS THAN 30 MINUTES DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491589 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE IMPACTOR BROKE WHILE IMPACTING THE FEMORAL COMPONENT TRIAL. A BACKUP DEVICE WAS AVAILABLE AND MORE THAN 30 MINUTES OF DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370472 ↗
• MalfunctionFeb 5, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE IMPACTOR BROKE. ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307635 ↗