JOURNEY 74022113Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556169810), received between Jun 2, 2018 and Jun 28, 2022 — classified as 9 injuries, 1 malfunction.

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 28, 2022Adverse 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, AN EARLY FEMORAL CONDYLE FRACTURE OCCURRED A WEEK AFTER THE PROCEDURE. THE ADVERSE EVENT HAS NOT BEING RESOLVE BUT A REVISION SURGERY IS BEING CONSIDERED. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Deformity/ Disfigurement

  MAUDE report 14847996 ↗
• MalfunctionJun 22, 2021Adverse 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 ON (B)(6) 2020, THE PATIENT EXPERIENCED RIGHT KNEE PAIN AND INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY REMOVING THE JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3 ((B)(4)) AND THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM ((B)(4)) ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 12046592 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED FROM FAILURE TO PROGRESS WITH FLEXION. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 10538604 ↗
• InjuryJun 18, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PROCEDURE, A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF BONE AND PAIN MADE BY THE PATIENT FALLING. THE REVISION SURGERY WAS NOT CAUSED BY SMITH&NEPHEW DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 10167308 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SUBJECT WAS HOSPITALISED AND WAS ADMINISTERED WITH ANTIBIOTIC THERAPY AND THE EVENT WAS RESOLVED AFTER 7 DAYS. PUNCTURE WAS TAKEN AND CULTURES WERE NEGATIVE.

  Patient problems: Unspecified Infection

  MAUDE report 8610473 ↗
• InjuryFeb 12, 2019Misassembled; Misassembled

  A REVISION SURGERY WAS PERFORMED DUE TO BASEPLATE HAD SUBSIDED AND BONE HAD FORMED AROUND IT. IT WAS REMOVED VIA FLEXIBLE OSTETOME AND PUNCH. FEMUR WAS REMOVED VIA GIGLI SAW AND FLEXIBLE OSTETOME. TIBIA, TEAMED TO 15 X 120, 4MM OFFSET USED, SIZE 3 BASEPLATE. ALL VIA STANDARD TECHNIQUE. TRIALLED. FEMUR, REAMED TO 15 X 160, SIZE 3. ALL VIA STANDARD TECHNIQUE. TRIALLED IMPLANTS WERE CEMENTED IN, 18MM CONSTRAINED TRIAL AND KNEE BALANCED AND THEN INSERTED. WOUND CLOSED.

  Patient problems: Injury

  MAUDE report 8334152 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO KNEE ARTHROFIBROSIS AND STIFFNESS WITH CORTISONE INJECTION INTO THE RIGHT KNEE.

  Patient problems: Fibrosis; Muscular Rigidity

  MAUDE report 7950144 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO KNEE ARTHROFIBROSIS AND STIFFNESS WITH CORTISONE INJECTION INTO THE RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 7949505 ↗
• InjuryOct 2, 2018Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO PAIN, SWELLING AND JOINT INSTABILITY. THE INSERT WAS REMOVED, THE OTHER COMPONENTS REMAINED.

  Patient problems: Joint Swelling; Pain

  MAUDE report 7929018 ↗
• InjuryJun 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE BECAUSE IT TAKES LONG TIME AFTER IMPLANTATION. THE PRODUCTS CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7564019 ↗

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-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-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