JOURNEY 71441353Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 03596010588050), received between Nov 7, 2018 and Aug 3, 2023 — classified as 12 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A JOURNEY LATERAL UKR, WHEN IMPACTING THE TIBIA, THE JRNY UNI TIBIAL IMPACTOR END SPLIT AND BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450923 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING INSPECTION A JRNY UNI TIBIAL IMPACTOR WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591329 ↗
• MalfunctionSep 12, 2022Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT, DURING INSPECTION, THE PLASTIC TIP OF A JRNY UNI TIBIAL IMPACTOR WAS BROKEN. AS NO CASE WAS INVOLVED, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407865 ↗
• MalfunctionAug 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A JRNY UNI TIBIAL IMPACTOR WAS BROKE. AS THIS WAS NOTICE UPON INSPECTION, NOT PATIENT WAS INVOLVED. INVESTIGATION DETERMINED THAT PIECES OF THE GRAY BUMPER BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332029 ↗
• MalfunctionAug 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY, WHEN USING THE JOURNEY UNI TIBIAL IMPACTOR TO IMPLANT THE TIBIAL BASEPLATE, THE GREY PLASTIC END BROKE UPON IMPACTION. THE SURGERY ENDED WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214215 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT IT WAS NOTICED THAT THE PLASTIC HEAD OF A JOURNEY UNI TIBIAL IMPACTOR HAS CRACKED AND IS STARTING TO COME APART OF THE DEVICE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108767 ↗
• MalfunctionJul 21, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT A JOURNEY UNI TIBIAL IMPACTOR BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. INVESTIGATION ALSO DETERMINED THAT THE BUMPER BROKE AND THE DOWEL PIN INTENDED FOR CONNECTING THE BUMPER TO THE TIBIAL IMPACTOR HANDLE IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073425 ↗
• MalfunctionMar 31, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE PLASTIC OF A JOURNEY UNI TIBIAL IMPACTOR IS CRACKED AND CHIPPING OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961843 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT, A JRNY UNI TIBIAL IMPACTOR WAS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866660 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY UNI TIBIAL IMPACTOR BROKEN UPON IMPLANTATION. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13858173 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY UNI TIBIAL IMPACTOR BROKEN UPON IMPLANTATION. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13857927 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY UNI TIBIAL IMPACTOR BROKEN UPON IMPLANTATION. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13857876 ↗
• MalfunctionMar 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC PIECE OF A JOURNEY UNI TIBIAL IMPACTOR POPPED OFF DURING THE LAST IMPACTION. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847969 ↗
• InjuryDec 27, 2021Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT, DURING SURGERY, UPON IMPACTION OF FINAL TIBIAL BASEPLATE WITH A JRNY UNI TIBIAL IMPACTOR, A CHUNK OF THE GREY PLASTIC BROKE OFF, AND THE IMPACTING TIP DOES NOT FIT THE SMALLER TIBIAS. DEVICE BROKE WHILE INSIDE THE PATIENT. 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 13087796 ↗
• InjuryDec 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY UNI TIBIAL IMPACTOR SHATTERED AT THE PLASTIC FOOT WHILE IMPACTING THE TIBIA; THE SMALL PLASTIC SHARDS HAD TO BE PAINSTAKINGLY RETRIEVED FROM THE JOINT AND RINSED OUT. SURGERY WAS RESUMED, WITH A LESS THAN TO 30 MINUTES 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 13047889 ↗
• MalfunctionOct 8, 2021Crack; Crack

  IT WAS REPORTED THAT, THE PLASTIC PIECE ON END OF A JRNY UNI TIBIAL IMPACTOR IS CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598330 ↗
• MalfunctionOct 5, 2021Crack; Crack

  IT WAS REPORTED THAT, THE IMPACTOR PIECE OF A JRNY UNI TIBIAL IMPACTOR WAS CRACKED FROM USED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580440 ↗
• MalfunctionSep 28, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKR SURGERY, A JOURNEY UNI TIBIAL IMPACTOR CRACKED DURING IMPLANTATION. SURGERY WAS COMPLETED WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544718 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED 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 12489295 ↗
• MalfunctionJul 30, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT AFTER A UKR, A JRNY UNI TIBIAL IMPACTOR, HAD A REPROCESSING PROBLEM AND IT WAS NOT REPROCESSED BY THE STERILE SERVICES, AFTER IT WAS USED IN A SURGERY PERFORMED IN (B)(6), THE DEVICE WAS BROKEN AND CRACKED. SURGERY WAS CANCELLED AS CONSEQUENCE OF THIS PROBLEM. PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250814 ↗
• MalfunctionJul 29, 2021Crack; Crack

  IT WAS REPORTED THAT THE PLASTIC ON THE TIP OF A JOURNEY UNI TIBIAL IMPACTOR APPEARS TO HAVE CRACKED OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243684 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JRNY UNI TIBIAL IMPACTOR BROKE, OUTSIDE OF PATIENT. 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 12171099 ↗
• InjuryMay 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE PLASTIC A JRNY UNI TIBIAL IMPACTOR BROKE WHILE IMPACTING THE TIBIA INSIDE THE PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814333 ↗
• MalfunctionApr 26, 2021Crack; Crack

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION THE JOURNEY UNI TIBIAL IMPACTOR HAD HAIRLINE CRACKS IN THE PLASTIC IMPACTOR AREA (BOTH PLASTIC PIECES). NO OTHER COMPLICATION WERE REPORTED THEREFORE NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729592 ↗
• MalfunctionApr 26, 2021Crack; Crack

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION THE JOURNEY UNI TIBIAL IMPACTOR HAD HAIRLINE CRACKS IN THE PLASTIC IMPACTOR AREA (BOTH PLASTIC PIECES). NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729591 ↗