JOURNEY 74012645Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556003343), received between Jul 20, 2020 and Jun 3, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

3 other recalls cover devices cleared under the same FDA submission (K111711); they may or may not involve this specific model.

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

• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE INNER RINGS ON ONE (1) TIBIAL SPACER BLOCK STANDARD BROKE OFF AND IT WAS UNABLE TO ATTACH THE ORANGE SHIMS TO IT. 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 22129775 ↗
• MalfunctionOct 9, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY THREE (3) TIBIAL SPACERS BLOCK STANDARD HAD THE LOCKING RINGS BROKEN OR GONE, AND WOULD NOT HOLD ORANGE SPACERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895429 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE INSIDE RINGS TO HOLD SPACER OF A TIBIAL SPACER BLOCK STANDARD ARE BROKEN AND WON'T HOLD SPACER. 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 17203808 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT ONE OF THE RINGS INSIDE THE TIBIAL SPACER BLOCK STANDARD IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341269 ↗
• MalfunctionJun 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE ORANGE PIECES WOULD NOT SNAP INTO THE TIBIAL SPACER BLOCK STANDARD, DUE TO A BROKEN INNER RING. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACKUP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860564 ↗
• MalfunctionJun 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, THE WHITE SNAP RINGS ON TIBIAL SPACER BLOCK STANDARD BROKE APART. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739822 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, THE LOCK RING OF THE TIBIAL SPACER BLOCK STANDARD BROKE. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640382 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIBIAL SPACER BLOCK STANDARD BROKE EXTERNAL TO THE PATIENT, AND NO PIECES FELL INSIDE. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310719 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY THE RUBBER RINGS IN THE TIBIAL SPACER BLOCK STANDARD WERE BROKEN SO NO ORANGE ATTACHMENTS CAN BE USED. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO PIECES FELL INSIDE THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486539 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT TIBIAL SPACER BLOCK STANDARD IS CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861293 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496762 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA THE HANDLE OF A TIBIAL SPACER BLOCK STANDARD DID NOT STAY IN PLACE. SURGERY WAS COMPLETED, WITHOUT DELAY, BY USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683532 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS REPORTED THAT THREE UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), THE TIBIAL SPACER BLOCK STANDARD ((B)(4)) THE JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR ((B)(4)) AND THE JOURNEY UNI TIBIAL TRAIL INSERT SIZE 3-4/ 9 MM ((B)(4)) WERE NOTICED CRACKED. THE SCREW DEPTH GAUGE ((B)(4)), META-TAN ANTI ROTATION BAR ((B)(4)), HUMERAL RULER ((B)(4)), TWO SCREW DRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) THE JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 5 ((B)(4)) AND 3.5 MM LOCKING SCREW GUIDE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593497 ↗
• MalfunctionMar 3, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE WAS NOTICED THE WHITE PLASTIC PIECE FROM INSIDE THE TIBIAL SPACER BLOCK STANDARD MISSING. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403051 ↗
• MalfunctionJan 5, 2021Break; Break

  IT WAS REPORTED THAT THE TIBIAL SPACER BLOCK STANDARD IS WORN WHERE THE QUICK CONNECT HANDLE ATTACHES AND WILL NOT STAY ATTACHED. NO CASE INVOLVED. RESULTS OF INVESTIGATION CONFIRMED THAT RINGS ON DEVICE ARE FRACTURED. 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 11120161 ↗
• MalfunctionJan 5, 2021Crack; Crack

  IT WAS REPORTED THAT, IN A TKA PROCEDURE, THE LOCKING RING OF A TIBIAL SPACER BLOCK STANDARD IS CRACKED AND DID NOT LOCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120153 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC RINGS OF THE TIBIAL SPACER BLOCK STANDARD ARE BROKEN AND THE ORANGE SHIMS WON¿T SNAP IN. FAULT IN DEVICE WAS NOTICED AFTER PROCEDURE AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911777 ↗
• InjuryNov 2, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIBIAL SPACER BLOCK STANDARD AND THE JOURNEY ART ISRT ASSM TOOL BROKE DUE TO NORMAL WEAR AND TEAR. THIS DID NOT HAPPEN INSIDE THE PATIENT AND ALL THE BROKEN PIECES WERE RECOVERED. THERE WAS NO DELAY AND NO BACK UP WAS AVAILABLE, SURGERY WAS COMPLETED USING OTHER INSTRUMENTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10775366 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TIBIAL SPACER BLOCK STANDARD BROKE OUTSIDE THE PATIENT, AND IT WILL STAY CONNECTED TO QUICK CONNECT HANDLE. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10659347 ↗
• InjuryJul 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY WHILE USING THE BLOCK THE SPACER WOULD NOT LOCK IN. THE SURGEON SAID THAT HE WOULD SIMPLY HOLD IT TOGETHER FOR THE MINIMAL TIME NEEDED AND WAS ABLE TO MOVE FORWARD WITH THE SURGERY. NO BACK UP ITEM WAS NEEDED, THERE WAS NO DELAY TO THE CASE, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10299250 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5