JOURNEY 74024626Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010554475), received between Sep 6, 2017 and Oct 4, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, K230653); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE JRNY BCS PATELLA BICONVEX 26 MM STD. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 10624622 ↗
• InjurySep 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE SURGEON ATTEMPTED TO INSERT THE SPEEDSCREW; HOWEVER, THE SUTURE WOULD NOT WIND THROUGH THE INTERNAL RATCHET. THERE WAS A BACKUP DEVICE AVAILABLE, WHICH WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10605975 ↗
• InjuryJun 27, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT HE PATELLA FELL OFF AND, SINCE IT WAS FLOATING IN THE KNEE, A REVISION SURGERY WAS REQUIRED TO REMOVE THE IMPLANT.

  Patient problems: Injury

  MAUDE report 8738123 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT LOST RANGE OF MOTION DUE TO ARTHROFIBROSIS AFTER TKA AND UNDERGO MANIPULATION UNDER ANESTHESIA TO REGAIN ROM.

  Patient problems: Injury

  MAUDE report 7042439 ↗
• InjuryOct 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR MONTHS AFTER A LEFT TKA THE PATIENT REQUIRED A LEFT KNEE MANIPULATION UNDER ANESTHESIA BECAUSE HE HAD DIFFICULTY REGAINING HIS PREOPERATIVE RANGE OF MOTION.

  Patient problems: No Code Available

  MAUDE report 6950382 ↗
• InjuryOct 6, 2017Loss of or Failure to Bond; Detachment Of Device Component; Device Dislodged or Dislocated; Loss of or Failure to Bond; Detachment Of Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT NEARLY A YEAR AFTER THE TKA A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT HAD DISCOMFORT AND PAIN WHILE WALKING. AFTER CHECKING, IT APPEARS THAT THE PATELLA IMPLANT WAS DISLOCATED OUTSIDE ITS SITE. THE UNSEALING CAME FROM THE PATELLA IMPLANT AND THE CEMENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6921367 ↗
• InjuryOct 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH RIGHT KNEE GENICULAR NEURALGIA AND RIGHT KNEE PAIN. THE SURGEON PERFORMED PROCEDURES: FLUOROSCOPIC GUIDANCE FOR NEEDLE REPLACEMENT, RIGHT SUPEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT SUPEROLATERAL GENICULAR BRANCH OF THE FEMORAL NERVE BLOCK, RIGHT INFEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT MEDIAL GENICULAR BRANCH FROM THE VASTUS INTERMEDIUS NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 6910906 ↗
• InjurySep 7, 2017Osseointegration Problem; Device Slipped; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROSCOPICAL REMOVAL OF PATELLAR COMPONENT DUE TO ITS LOOSENING.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6847582 ↗
• InjurySep 6, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD AN INJURY PLAYING GOLF IN WHICH HE FELT A POP AND PAIN/SWELLING IN THE KNEE. X-RAY SHOWED PATELLAR COMPONENT DISLODGED AND REMOVAL OF PATELLA WAS DONE ARTHROSCOPICALLY. AFTER REMOVAL OF PATELLAR COMPONENT, PATIENT FAILED TO IMPROVE AND ON (B)(6) 2015 KNEE REVISION OF THE PATELLAR COMPONENT WITH A POSSIBLE LATERAL RELEASE WAS DONE.

  Patient problems: Injury; Joint Dislocation; Joint Swelling; Pain

  MAUDE report 6844520 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112
• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7