JOURNEY 71935180Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00885556578445), received between Jan 7, 2020 and Jun 12, 2026 — classified as 10 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Fracture” (54 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 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Fracture

  IT WAS REPORTED THAT, DURING AN UKA, ONE (1) GAP SPACER FRACTURED. NOTHING FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494305 ↗
• MalfunctionMay 1, 2026Fracture

  IT WAS REPORTED THAT DURING A UKA SURGERY, THE GAP SPACER SNAPPED. NOTHING WENT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062402 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GAP SPACER BROKE DURING TRIALING DUE TO THE KNEE BEING DESCRIBED AS ¿SUPER TIGHT¿. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520563 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT DURING A UKR, SINCE THERE WAS A TIGHT FLEXION GAP WHILE THE SURGEON ATTEMPT TO CHECK THIS GAP ONE (1) GAP SPACER BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455247 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT, DURING A UKA SURGERY, WHILE ATTEMPTING TO INSERTED ONE (1) GAP SPACER BETWEEN THE POLY TRIAL AND FEMORAL, IT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177286 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKR, THE GAP SPACER SNAPPED IN HALF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE SURGICAL SITE. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785187 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKA SURGERY, ONE (1) GAP SPACER BROKE IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777796 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PKR SURGERY, ONE (1) GAP SPACER BROKE WHILE IT WAS BEING USED. 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 23657118 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GAP SPACER BROKE IN HALF. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640325 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GAP SPACER CHECK SNAPPED WHEN IT TOOK THE KNEE FROM EXTENSION TO FLEXION. ALL PIECES RETRIEVED AD REMOVED BY HAND. NO NOTES OR X-RAYS. 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 23511611 ↗
• InjuryOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKA SURGERY PERFORMED ON (B)(6) 2025, THE GAP SPACER BROKE DURING CEMENTING AND CAUSED A SIGNIFICANT DELAY IN THE CASE. THE PIECE THAT BROKE WAS INACCESSIBLE WITH IMPLANTS IN AS IT HAD FALLEN INTO THE POSTERIOR MEDIAL COMPARTMENT BEHIND THE TIBIA. THIS ADVERSE EVENT WAS TREATED BY REMOVING THE CEMENTED IMPLANTS AND CONVERT TO A TOTAL KNEE TO RETRIEVE TO BROKEN PIECE. PATIENT'S CURRENT HEALTH STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288596 ↗
• MalfunctionOct 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKR, WHEN TESTING THE GAP SPACING, THE GAP SPACER BROKE IN HALF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23191121 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT ONE (1) GAP SPACER WAS BROKEN AND UNFIT FOR USE. THE PROCEDURE WAS RESUMED WITHOUT DELAY. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075533 ↗
• MalfunctionSep 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER USING THE GAP SPACER, THE SURGEON SNAPPED IT IN HALF, TAKING OUT OF THE JOINT. THE PIECE WAS RETRIEVED BY HAND, AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE HAD BEEN COMPLETED, 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 23042514 ↗
• MalfunctionAug 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING UKR SURGERY, ONE (1) GAP SPACER SNAPPED AT THE 2-3MM JUNCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22842558 ↗
• MalfunctionJul 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) GAP SPACER BROKE WHILE BEING USED. IT IS UNKNOWN IF THIS CAUSED ANY DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22618883 ↗
• MalfunctionApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A UKR SURGERY, ONE (1) GAP SPACER SNAPPED IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL 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 21921144 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UKA SURGERY, ONE (1) GAP SPACER BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY OR INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764520 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GAP SPACER BROKE WHILE TRIALING. 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 21697666 ↗
• MalfunctionFeb 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING A UKR (NAVIO) SURGERY, THE GAP SPACER BROKE WHILE SURGEON WAS BALANCING KNEE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21491599 ↗
• MalfunctionFeb 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKR, A (1) GAP SPACER BROKE IN HALF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 21375679 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING UKA SURGERY, THE GAP SPACER WAS BROKEN OFF. ALL THE BROKEN PIECES WERE REMOVED AND ACCOUNTED. 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 21085699 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN UKA SURGERY, ONE (1) GAP SPACER BROKE WHILE CHECKING LAXITY IN FLEXION. ALL BROKEN PIECES WERE REMOVED BY HAND. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085233 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GAP SPACER SNAPPED WHILE CHECKING GAPS. 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 20861089 ↗
• MalfunctionDec 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA CASE, A GAP SPACER BROKE IN HALF WHILE ASSESSING JOINT LAXITY. THE PROCEDURE WAS COMPLETED, 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 20851207 ↗