ORTHOMATCH 71442109Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556494356), received between Dec 6, 2017 and Dec 18, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE CUTTING BLOCK HAD A SPACE WHERE THE SAW PASSES THAT WAS TOO LARGE, MAKING A PERFECT CUT DIFFICULT. A RISK OF INJURY TO THE PATIENT WAS REPORTED, AS THE EXCESSIVE OPENING COULD HAVE CAUSED AN IMPERFECT CUT. 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 23843504 ↗
• MalfunctionSep 27, 2024Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE ORTHOMATCH UNIVERSAL CUT BLOCK HAD VERY OPEN CUTTING SPACES AND CAUSED THE DISTAL CUT TO BE MADE TOO POSTERIOR AND WHEN USED, THE BLOCK LOST ITS REFERENCE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 20323417 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING USE, A ORTHOMATCH UNIVERSAL CUT BLOCK WAS NOTICED TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210153 ↗
• MalfunctionNov 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A ORTHOMATCH UNIVERSAL CUT BLOCK BROKE. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AS CONSEQUENCE OF THE ISSUE OR IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURIES TO THE PATIENT WERE REPORTED. 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 15777468 ↗
• MalfunctionMar 25, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ORTHOMATCH UNIVERSAL CUT BLOCK PRESENTED AN EXCESSIVE WEAR AND DID NOT CUT PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572407 ↗
• InjuryJul 23, 2020Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY THE DEVICE WAS BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317783 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT CUT BLOCKS BROKE WHILE BEING USED DURING SURGERY. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727641 ↗
• MalfunctionJul 24, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A MALFUNCTION HAS OCCURED IN WHERE THE CUTTING BLOCK DETACHES FROM THE ATTACHMENT AND WAS NOT HOLDING FIRMLY, IT WAS VERY LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715971 ↗
• InjuryJul 23, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSTRUMENT WAS NOT HOLDING FIRMLY TO 3' CONNECTOR AND IT KEPT FALLING OFF INCREASING THEATRE TIME AND CAUSING INAPPROPRIATE TIBIAL CUTS. SURGEON FINISHED SURGERY USING COMPETITOR'S DEVICE.

  Patient problems: No Code Available

  MAUDE report 7712112 ↗
• InjuryJun 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DEVICE DIDN'T ATTACH FIRMLY TO THE TIBIAL 3¿ CONNECTOR, WHEN CUTTING THE PROXIMAL TIBIAL CUTS THE CUTS WERE NOT HORIZONTAL, WHEN THE SURGEON PUT THE TRIAL TIBIAL IMPLANT AND INSERT, THE PATELLA WAS NOT TRACKING WELL, UPON RECHECKING ON THE CUTS, IT WAS NOTICED THE CUT WASN¿T PARALLEL DUE TO LOOSENING OF THE BLOCK.

  Patient problems: Injury

  MAUDE report 7585363 ↗
• MalfunctionDec 6, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT EVEN THOUGH THE ORTHOMATCH UNIVERSAL PRIMARY CUTTING BLOCK WAS ATTACHED FIRMLY THE ALIGNMENT WAS INCORRECT RESULTING IN A VALGUS DETERMINATION ON THE FEMORAL CUTS AND POOR INCLINATION ON THE TIBIAL CUTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088664 ↗