JOURNEY 74027253Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556179468), received between Feb 19, 2018 and Jun 7, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 5-6 RT 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19491135 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT KNEE REPLACEMENT WITH JOURNEY II BCS SYSTEM HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT HAS STATED THAT HE CANNOT LIVE WITH THE PAIN THAT IT CAUSES EVERY TIME HE BENDS THE KNEE OR WALKS. THE PATIENT HAS ALSO CLAIMED THAT (I) THE SURGEON WHO IMPLANTED THE SYSTEM DID NOT ADDRESS THE REACTIONS HE EXPERIENCED ON THE KNEE AT FIRST, SO HE CONSULTED ANOTHER SURGEON FOR A SECOND OPINION; (II) THE NEW SURGEON INDICATED THAT THE KNEE REQUIRES A REVISION SURGERY, WHICH WILL BE PERFORMED IN MAY; (III) SOMETHING NOT RIGHT THERE AND NOBODY SEEMS TO KNOW HOW TO FIX IT, ALTHOUGH HE BELIEVES THAT THE PROBLEM IS THE INSERT BECAUSE HIS RESEARCH SHOWED THAT S+N HAS RECALLED SIMILAR PARTS. THE EVENT IS ONGOING.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Inadequate Osseointegration; Swelling/ Edema

  MAUDE report 18927164 ↗
• InjuryAug 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A RIGHT TKA, THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 11MM SHEARED OFF AND THE KNEE WAS UNSTABLE. THE SURGEON MENTIONED THERE COULD HAVE BEEN SOME CEMENT EXTRUDED IN THE BOX, THAT MIGHT HAVE CAUSED WEAR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WHERE A BCS CONSTRAINED 5-6, 11 RIGHT WAS INSERTED AND FUNCTIONED WELL. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15274677 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A DISLOCATION: THE KNEE JUMPED THE INSERT POST. A REVISION SURGERY WAS PERFORMED TO TAKE THE 11 MM STANDARD INSERT OUT, WHICH WAS STILL LOCATED AND LOCKED INTO THE TIBIAL BASEPLATE, AND PUT A 12 MM CONSTRAINED INSERT IN. THE SURGEON WAS HAPPY WITH THE RESULT.

  Patient problems: Joint Dislocation

  MAUDE report 10817435 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS DISCUSSED TO BE PERFORMED DUE TO PATIENT PRESENTING PAIN. SURGEON EXPLANTED THE FEMUR, TIBIA AND INSERT WITH MINIMAL BONE LOSS. HE USED J&J REVISION IMPLANTS. THE PATIENT RECEIVED THE PRIMARY SURGERY ON (B)(6) 2019. THE PATELLA WAS LEFT. THE SURGEON COULD NOT CLINICALLY FIND ANY PROBLEMS FOR PATIENT¿S COMPLAINT OF PAIN, EXCEPT FOR A PROBABLE LIMITED POSTERIOR SLOPE ON TIBIA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Extravasation; Injury; Pain

  MAUDE report 10522885 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED BILATERAL PULMONARY EMBOLISM AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH HOSPITALIZATION AND MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAD TO RECEIVE REMEDIAL THERAPY TO RESOLVE THE ADVERSE EVENT.

  Patient problems: Pulmonary Embolism

  MAUDE report 8600434 ↗
• InjuryMay 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LIMITED RANGE OF MOTION AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH MANIPULATION UNDER ANESTHESIA WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8584921 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE, PATIENT EXPERIENCED PAIN IN HIS RIGHT KNEE. NO SIGNS OF NEUROPATHIC PAIN. KNEE WAS WARM AND SWOLLEN. PATIENT REQUIRED HOSPITALIZATION. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Pain

  MAUDE report 8479204 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION THERE WAS A SURGERY COMPLICATION, PATIENT HAD A PULMONARY EMBOLISM/ DVT.

  Patient problems: Pulmonary Embolism; Thrombosis

  MAUDE report 8051054 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL AND TORE THE QUAD TENDON WHICH RESULTED IN THE NEED TO REPLACE THE INSERT.

  Patient problems: Injury

  MAUDE report 7280123 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

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