JOURNEY II XR 74022203Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556615331), received between Sep 11, 2018 and Mar 21, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K152726, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PATIENT SUFFERED A TIBIAL INTERCONDYLAR EMINENCE FRACTURE, AFTER CEMENTATION OF THE PROSTHESIS. FRACTURE WAS FIXATED, AFTER A NON-SIGNIFICANT DELAY, WITH A SCREW DURING SURGERY. PATIENT CURRENT HEALTH STATUS IS HEALTHY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16587415 ↗
• InjuryJun 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN (B)(6) 2019 WITH A JOURNEY II XR SYSTEM, PATIENT EXPERIENCED LOOSENING IN THEIR LEFT KNEE. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JRNY II XR BASEPLATE SZ 3 LT ALONG WITH THE INSERT TO RESOLVE THE REPORTED EVENT.

  Patient problems: Joint Laxity

  MAUDE report 14655074 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS ADDRESSED BY PERFORMING A REVISION SURGERY: ALL COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10766987 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED LEFT KNEE HEMARTHROSIS AND CELLULITIS. THE EVENT WAS RESOLVED VIA REVISION SURGERY. THE EVENT IS CONSIDERED ONGOING.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9997221 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT HAD BEEN EXPERIENCING PROBLEMS ASSOCIATED WITH STIFFNESS ON HIS SURGERY KNEE. THE SUBJECT ATTEMPTED PHYSICAL THERAPY BUT ENDED UP DEVELOPING ARTHROFIBROSIS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND ITS OUTCOME IS CONSIDERED UNKNOWN.

  Patient problems: Injury

  MAUDE report 9983993 ↗
• InjuryApr 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED STIFFNESS OF LEFT KNEE. EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9951764 ↗
• InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED FROM LEFT KNEE ARTHROFIBROSIS FOLLOWING A SURGERY. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9911097 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LEFT KNEE STIFFNESS. THE SUBJECT WAS HOSPITALIZED AND MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE ISSUE WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9901104 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM LEFT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND IT'S CONSIDERED RESOLVED WITH RESIDUES.

  Patient problems: Injury

  MAUDE report 9901085 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS OF THE LEFT KNEE. THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 9253270 ↗
• InjurySep 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TIBIA PAIN.

  Patient problems: Pain

  MAUDE report 8958209 ↗
• InjuryAug 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT MANIPULATION UNDER ANESTHESIA WAS REQUIRED DUE TO STIFFNESS.

  Patient problems: Injury

  MAUDE report 8929066 ↗
• InjuryJun 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Fibrosis

  MAUDE report 8746886 ↗
• InjuryJun 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MUA WAS PERFORMED DUE TO STIFFNESS IN LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8681396 ↗
• InjuryJun 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT SUBJECT DEVELOPED STIFFNESS DECIDED TO PROCEED WITH MUA WHICH RESOLVED THE EVENT.

  Patient problems: Injury

  MAUDE report 8681337 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN IN THE LEFT KNEE, WHICH WAS TREATED CONSERVATIVELY.

  Patient problems: Pain

  MAUDE report 8660942 ↗
• InjurySep 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED FOR A PATIENT DUE TO A FRACTURE OF THE MEDIAL ASPECT OF LEFT PROXIMAL TIBIAL METAPHYSIS.

  Patient problems: Injury

  MAUDE report 7866783 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152726, 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