JOURNEY II XR 74023740Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556612835), received between Jan 31, 2018 and Nov 10, 2020 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2017 IN WHICH JOURNEY II XR ART INSERT XLPE MED SZ 3-4 LT 8MM WAS IMPLANTED. DEVICE WAS EXCHANGED THREE YEARS LATER DUE TO PATIENT LAXITY ISSUES AND PATELLA WEAR (PATELLA WAS NOT RESURFACED ON JAN. 23, 2017). PATIENT OUTCOME IS CURRENTLY UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Laxity; No Code Available; Pain

  MAUDE report 10814709 ↗
• 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 9983253 ↗
• 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 9901097 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  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 9901083 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STIFFNESS AND WRONG ROM. SURGEON DOES NOT BLAME THE IMPLANTS.

  Patient problems: Injury

  MAUDE report 9774080 ↗
• 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 9253293 ↗
• 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 8746894 ↗
• InjuryJun 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CLOSED MANIPULATION UNDER ANESTHESIA HAS BEEN DONE DUE TO STIFFNESS IN THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8746840 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT INCISION AND DRAINAGE WERE PERFORMED TO THE PATIENT DUE TO WOUND DRAINAGE CAUSED BY AN ALLERGIC REACTION TO SUTURES.

  Patient problems: Injury

  MAUDE report 8712725 ↗
• 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 8681341 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE INFLAMMATION 3 YEARS AFTER THE SURGERY AND PATIENT WAS GIVEN PREDNISONE.

  Patient problems: Inflammation

  MAUDE report 8079988 ↗
• 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 7866733 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT KNEE PRESENTED STIFFNESS; DECREASED ROM. EVENT WAS TREATED WITH SURGICAL PROCEDURE - MANIPULATION UNDER ANESTHESIA. (B)(6) DISAGREED WITH INVESTIGATOR'S CLASSIFICATION THAT THIS EVENT IS UNRELATED AND HAS CLASSIFIED THIS EVENT ON 20.08.2018 AS SERIOUS ADVERSE DEVICE EFFECT (SADE), UNABLE TO EXCLUDE RELATIONSHIP OF S&N DEVICE AS CAUSE OR CONTRIBUTOR TO THIS SERIOUS INJURY, WITH SPECIAL EMPHASIS GIVEN TO SURGICAL TECHNIQUE.

  Patient problems: Loss of Range of Motion; Neck Stiffness

  MAUDE report 7846480 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A LACK OF RANGE OF MOTION AND PAIN. ONCE THE POLYS WERE REMOVED, IT WAS NOTICED THAT THEY SHOW SIGNS OF WEAR. THE PATIENT NOW HAD GREAT RANGE OF MOTION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7231060 ↗

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